Us Fda Approved Drug List

Dermatology/Plastic Surgery
Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012 Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012 Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012 Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012
Endocrinology
Bio-T-Gel (testosterone gel); Teva Pharmaceuticals; For the treatment of hypogonadism, Approved February 2012 Elelyso (taliglucerase alfa); Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012 Jentadueto (linagliptin plus metformin hydrochloride); Eli Lilly; For the treatment of type II diabetes, Approved February 2012 Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with endogenous Cushings syndrome, Approved February 2012 Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012 Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012
Gastroenterology
Elelyso (taliglucerase alfa); Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012 Ultresa (pancrelipase) delayed-release capsules; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, Approved March 2012 Viokace (pancrelipase) tablets; Aptalis Pharma; For the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy, Approved March 2012
Hematology
Elelyso (taliglucerase alfa); Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012 Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012
Immunology/Infectious Diseases
Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012 Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Musculoskeletal
Elelyso (taliglucerase alfa); Pfizer Inc; For the treatment of Gaucher disease, Approved May 2012 Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012 Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012 Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012
Nephrology/Urology
Afinitor (everolimus); Novartis Pharmaceuticals Corporation; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012 Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012 Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease, Approved March 2012 Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012 Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012
Neurology
Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of postherpetic neuralgia, Approved June 2012 Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012 Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012
Obstetrics/Gynecology
Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer HealthCare; For the treatment of heavy menstrual bleeding, Approved March 2012 Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012
Oncology
Afinitor (everolimus); Novartis Pharmaceuticals Corporation; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012 Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012 Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012 Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012 Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012 Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012 Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012
Ophthalmology
Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular pressure, Approved February 2012
Otolaryngology
Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012 Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012
Pediatrics/Neonatology
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012 Sklice (ivermectin) lotion; Sanofi Pasteur; For the treatment of head lice, Approved February 2012 Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012
Pharmacology/Toxicology
Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate concentrations in patients with impaired renal function, Approved January 2012
Pulmonary/Respiratory Diseases
Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc.; For the relief of symptoms of seasonal allergic rhinitis, Approved May 2012 Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D mutation in the CFTR gene, Approved January of 2012 Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved March 2012 Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome in premature infants, Approved March 2012
Rheumatology
Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012
Cardiology/Vascular Diseases
Brilinta (ticagrelor); AstraZeneca; For the reduction of thrombotic events in patients with acute coronary syndrome, Approved July 2011 Edarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February 2011 Edarbyclor (azilsartan medoxomil and chlorthalidone); Takeda Pharmaceutical; For the treatment of hypertension, Approved December of 2011 Xarelto (rivaroxaban); Janssen Pharmaceuticals; For the reduction in the risk of stroke and systemic embolism resulting from atrial fibrillation, Approved November 2011 Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011
Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011 Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011 laViv (azficel-T); Fibrocell Science; For the improvement of nasolabial fold wrinkles in adults, Approved June 2011 Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011 Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011 Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011
Endocrinology
Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011 Juvisync (sitagliptin and simvastatin); Merck; For the treatment of type II diabetes, Approved October 2011 Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011 Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May 2011
Gastroenterology
Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011 Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011 Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011 Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011 Rectiv (nitroglycerin) ointment 0.4%; ProStrakan; For the treatment of chronic anal fissure, Approved June 2011 Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011 Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011
Hematology
Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011 Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia, Approved November of 2011 Ferriprox (deferiprone); Apotex; For the treatment of transfusional iron overload due to thalassemia, Approved October 2011 Jakafi (ruxolitinib); Incyte; For the treatment of myelofibrosis, Approved November 2011 Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011 Xarelto (rivaroxaban); Bayer; For the prophylaxis of deep vein thrombosis during knee or hip replacement surgery, Approved July 2011
Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011 Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus erythematosus, Approved March 2011 Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate); Gilead; For the treatment of HIV-1 in treatment-naive adults, Approved August of 2011 Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011 Dificid (fidaxomicin); Optimer Pharmaceuticals; For the treatment of Clostridium difficile-associated diarrhea, Approved May 2011 Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011 Firazyr (icatibant); Shire; For the treatment of acute attacks of hereditary angioedema, Approved August of 2011 Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011 Incivek (telaprevir); Vertex; For the treatment of genotype 1 chronic hepatitis C, Approved May 2011 Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011 Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May 2011
Musculoskeletal
Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011 Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011
Nephrology/Urology
Anturol (oxybutynin) Gel; Antares Pharma; For the treatment of overactive bladder, Approved December 2011 Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney transplant, Approved June 2011 Soliris (eculizumab); Alexion; For the treatment of atypical hemolytic uremic syndrome, Approved September 2011
Neurology
Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011 Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved November 2011 Gralise (gabapentin); Abbott; For the treatment of postherpetic neuralgia, Approved February 2011 Horizant (gabapentin enacarbil); GlaxoSmithKline; For the treatment of restless legs syndrome, Approved April 2011 Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved November 2011 Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011 Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011 Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011 Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved June 2011 Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011
Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm birth, Approved February 2011
Oncology
Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011 Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011 Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011 Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia, Approved November of 2011
Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011 Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011 Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011 Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011 Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011 Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011 Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011 Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011
Ophthalmology
Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of neovascular (wet) age-related macular degeneration, Approved November 2011
Otolaryngology
Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011
Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011 Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011 Onfi (clobazam); Lundbeck; For the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome, Approved October 2011
Oxecta (oxycodone HCl); Pfizer; For the management of acute and chronic moderate to severe pain, Approved June 2011
Psychiatry/Psychology
Intermezzo (zolpidem tartrate sublingual tablet); Transcept Pharmaceuticals; For the treatment of insomnia, Approved November 2011 Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder, Approved January 2011
Arcapta (indacaterol maleate inhalation powder); Novartis; For the treatment of airflow obstruction resulting from chronic obstructive pulmonary disease, Approved July 2011 Daliresp (roflumilast); Forest Pharmaceuticals; For the treatment of chronic obstructive pulmonary disease, Approved February 2011 Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011
Rheumatology
Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011 Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011
Trauma/Emergency Medicine
Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical analgesia, Approved November 2011
Amturnide (aliskiren + amlodipine + hydrochlorothiazide); Novartis; For the treatment of uncontrolled hypertension, Approved December 2010 Pradaxa (dabigatran etexilate mesylate); Boehringer Ingeleheim; For the risk reduction of stroke and embolism due to atrial fibrillation, Approved October 2010 Tekamlo (aliskiren + amlodipine); Novartis; For the treatment of hypertension, Approved August 2010 Tribenzor (olmesartan medoxomil + amlodipine + hydrochlorothiazide); Daiichi Sankyo; For the treatment of hypertension, Approved July 2010
Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010 Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010
Zyclara (imiquimod); Graceway; For the treatment of actinic keratoses of the face and scalp, Approved March 2010
Endocrinology
Fortesta (testosterone gel); Endo Pharmaceuticals; For the treatment of hypogonadism, Approved December 2010 Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010 Victoza (liraglutide); Novo Nordisk; For the treatment of type 2 diabetes mellitus, Approved January 2010
Gastroenterology
Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010 Pancreaze (pancrelipase); Johnson & Johnson; For the treatment of exocrine pancreatic insufficiency, Approved April of 2010 Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010 Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010
Hematology
Vpriv (velaglucerase alfa for injection); Shire; For the treatment of type 1 Gaucher disease, Approved March 2010
Cayston (aztreonam for inhalation solution); Gilead Sciences; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010 Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010
Menveo (meningitis vaccine); Novartis; For the active immunization to prevent invasive meningococcal disease, Approved February 2010 Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April 2010 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine); Wyeth; For the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae, Approved February 2010 Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010 Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney transplant, Approved May 2010 Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 2010
Musculoskeletal
Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved January 2010 Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010 Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010 Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved September 2010 Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010 Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010 Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010
Xeomin (incobotulinumtoxinA); Merz Pharmaceutical; For the treatment of cervical dystonia and blepharospasm, Approved July 2010 Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010 Xiaflex (collagenase clostridium histolyticum); Auxilium Pharmaceuticals; For the treatment of Dupuytrens contracture, Approved February 2010
Nephrology/Urology
Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March 2010 Jalyn (dutasteride + tamsulosin); GlaxoSmithKline; For the treatment of benign prostatic hyperplasia, Approved June 2010 Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010 Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010 Xifaxan (rifaximin); Salix; For the treatment of hepatic encephalopathy, Approved March 2010 Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney transplant, Approved May 2010
Neurology
Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010 Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010 Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October 2010 Butrans (buprenorphine) Transdermal System; Purdue Pharma; moderate to severe chronic pain, Approved July 2010
Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March 2010 Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010 Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of moderate to severe pain, Approved March 2010 Kapvay (clonidine hydrochloride); Shionogi Pharma; For the treatment of attention deficit hyperactivity disorder, Approved October 2010 Nuedexta (dextromethorphan hydrobromide and quinidine sulfate); Avanir Pharmaceuticals; For the treatment of pseudobulbar affect, Approved October 2010 Silenor (doxepin); Somaxon Pharma; For the treatment of insomnia, Approved March 2010 Sprix (ketorolac tromethamine); Roxro Pharma; For the treatment of moderate to severe pain, Approved May 2010 Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010 Vpriv (velaglucerase alfa for injection); Shire; For the treatment of type 1 Gaucher disease, Approved March 2010 Xifaxan (rifaximin); Salix; For the treatment of hepatic encephalopathy, Approved March 2010
ella (ulipristal acetate); HRA Pharma; For the emergency prevention of contraception, Approved August 2010 Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010 Natazia (estradiol valerate + dienogest); Bayer; For the prevention of contraception, Approved May 2010 Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010
Oncology
Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010 Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010 Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010 Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010 Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010 Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010
Ophthalmology
Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis, Approved May 2010
Otolaryngology
Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April 2010
Cuvposa (glycopyrrolate); Shionogi; For the treatment of chronic severe drooling in pediatrics with neurologic conditions, Approved July 2010 Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010 Kapvay (clonidine hydrochloride); Shionogi Pharma; For the treatment of attention deficit hyperactivity disorder, Approved October 2010
Veltin (clindamycin phosphate and tretinoin); Stiefel; For the treatment of acne vulgaris, Approved July 2010
Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, Approved November 2010 Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010
Latuda (lurasidone); Sunovion; For the treatment of schizophrenia, Approved October 2010 Oleptro (trazodone hydrochloride); Labopharm; For the treatment of major depressive disorder, Approved February 2010 Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention of relapse to opioid dependence, Approved October 2010
Cayston (aztreonam for inhalation solution); Gilead Sciences; For the treatment of cystic fibrosis patients with Pseudomonas aeruginosa, Approved February 2010 Dulera (mometasone furoate + formoterol fumarate dihydrate); Merck; For the treatment of asthma, Approved June 2010 Teflaro (ceftaroline fosamil); Cerexa; For the treatment of bacterial skin infections and bacterial pneumonia, November 2010
Rheumatology
Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved January 2010 Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010
Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010
Trauma/Emergency Medicine
Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010
Cleviprex (clevidipine); The Medicines Company; For the treatment of hypertension when oral therapy is not feasible or not desirable, Approved August 2008 Trilipix (fenofibric acid); Abbott Laboratories; For the treatment of dyslipidemia, hypertriglyceridemia and hyperlipidemia, Approved December 2008
Endocrinology
Accretropin (somatropin rDNA Original); Cangene Corp; For the treatment of growth failure in pediatrics, Approved January 2008 Welchol (colesevelam hydrochloride); Daiichi Sankyo; For the improvement of glycemic control in adults with type 2 diabetes mellitus, Approved January 2008
Gastroenterology
Cimzia (certolizumab pegol); UCB; For the treatment of Crohns disease, Approved April 2008 Entereg (alvimopan); GlaxoSmithKline; For the treatment of postoperative ileus, Approved May 2008 Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008 Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved September 2008 Tysabri (natalizumab); Biogen IDEC; For the maintenance treatment of moderate to severe Crohns disease, Approved January 2008
Hematology
Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkins lymphoma and multiple myeloma, Approved December 2008 Nplate (romiplostim); Amgen; For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, Approved August 2008 Promacta (eltrombopag); GlaxoSmithKline; For the treatment of thrombocytopenia, Approved November 2008
Aptivus (tipranavir); Boehringer Ingelheim; For the treatment of HIV, Approved June 2008 Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved October 2008 Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema, Approved October 2008 Intelence (etravirine); Tibotec; For the treatment of HIV-1, Approved January 2008 Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 2008 Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008 Tysabri (natalizumab); Biogen IDEC; For the maintenance treatment of moderate to severe Crohns disease, Approved January 2008 Viread (tenofovir disoproxil fumarate); Gilead; For the treatment of hepatitis B, Approved August 2008
Musculoskeletal
Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008 Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's disease, Approved August 2008
Nephrology/Urology
Degarelix (degarelix for injection); Ferring Pharmaceuticals; For the treatment of prostate cancer, Approved December of 2008 Toviaz (fesoterodine fumarate); Pfizer; For the treatment of overactive bladder, Approved October 2008
Neurology
Banzel (rufinamide); Elan Pharmaceuticals; For the treatment of seizures associated with Lennox-Gastaut syndrome in pediatrics and adults, Approved November 2008 Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain associated with ocular surgery, Approved June 2008 Lusedra (fospropofol disodium); Elan Pharmaceuticals; A sedative-hypnotic agent indicated for monitored anesthesia care sedation, Approved December of 2008 Nucynta (tapentadol); Ortho-McNeil Janssen; moderate to severe acute pain, Approved November 2008 Stavzor (valproic acid delayed release); Banner Pharmacaps; For the treatment of bipolar manic disorder, seizures and migraine headaches, Approved July 2008 Vimpat (lacosamide); Schwarz Pharma; For the treatment of partial-onset seizures in adults with epilepsy, Approved October 2008 Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's disease, Approved August 2008
Oncology
Degarelix (degarelix for injection); Ferring Pharmaceuticals; For the treatment of prostate cancer, Approved December of 2008 Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate therapy in osteosarcoma and to reduce the toxicity of methotrexate, Approved March of 2008 Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkins lymphoma and multiple myeloma, Approved December 2008 Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved September 2008 Treanda (bendamustine hydrochloride); Cephalon; For the treatment of Chronic lymphocytic leukemia and B-cell nonHodgkins lymphoma, Approved October 2008
Ophthalmology
Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures, Approved October 2008
Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved October 2008 Durezol (difluprednate); Sirion Therapeutics; For the treatment of inflammation and pain associated with ocular surgery, Approved June 2008
Otolaryngology
Astepro (azelastine hydrochloride nasal spray); Meda Pharmaceuticals; For the treatment of seasonal and perennial allergic rhinitis, Approved October 2008 Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 2008 Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008
Accretropin (somatropin rDNA Original); Cangene Corp; For the treatment of growth failure in pediatrics, Approved January 2008 Alvesco (ciclesonide); Nycomed; For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents, Approved January 2008 Aptivus (tipranavir); Boehringer Ingelheim; For the treatment of HIV, Approved June 2008 Banzel (rufinamide); Elan Pharmaceuticals; For the treatment of seizures associated with Lennox-Gastaut syndrome in pediatrics and adults, Approved November 2008 Cinryze (C1 Inhibitor (Human)); Lev Pharmaceuticals; For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema, Approved October 2008 Moxatag (amoxicillin); MiddleBrooke Pharmaceuticals; For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics, Approved January 2008 Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008 Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008 Rotarix (Rotavirus Vaccine, Live, Oral); GlaxoSmithKline; For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics, Approved April 2008
Akten (lidocaine hydrochloride); Akorn; For anesthesia during ophthalmologic procedures, Approved October 2008 Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate therapy in osteosarcoma and to reduce the toxicity of methotrexate, Approved March of 2008 Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved September 2008
Aplenzin (bupropion hydrobromide); Biovail Laboratories; For the treatment of major depressive disorder, Approved April 2008 Stavzor (valproic acid delayed release); Banner Pharmacaps; For the treatment of bipolar manic disorder, seizures and migraine headaches, Approved July 2008
Alvesco (ciclesonide); Nycomed; For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents, Approved January 2008 Patanase (olopatadine hydrochloride); Alcon; For the treatment of seasonal allergic rhinitis, Approved April 2008
Rheumatology
Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008
Azor (amlodipine besylate; olmesartan medoxomil); Daiichi Sankyo; For the treatment of hypertension, Approved September 2007 Fenofibrate; LifeCycle Pharma; For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia, Approved August 2007 Letairis (ambrisentan); Gilead; For the treatment of pulmonary arterial hypertension, Approved June 2007 Soliris (eculizumab); Alexion Pharm; For the treatment of paroxysmal nocturnal hemoglobinuria, Approved March 2007 Tekturna (aliskiren); Novartis; For the treatment of hypertension, Approved March 2007
Altabax (retapamulin); GlaxoSmithKline; For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007 Extina (ketoconazole); Stiefel; For the treatment of seborrheic dermatitis, Approved June 2007 Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Endocrinology
Evamist (estradiol); Vivus; For the treatment of moderate to severe vasomotor symptoms due to menopause, Approved July 2007 Fenofibrate; LifeCycle Pharma; For the treatment of hyperlipidemia, dyslipidemia and hypertriglyceridemia, Approved August 2007 Somatuline Depot (lanreotide acetate); Beaufour Ipsen; For the treatment of acromegaly, Approved August 2007 Supprelin LA (histrelin acetate); Indevus Pharmaceuticals; For the treatment of central precocious puberty, Approved May 2007
Hematology
Kuvan (sapropterin dihydrochloride); BioMarin Pharmaceuticals; For the treatment of hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria, Approved December 2007 Mircera (methoxy polyethylene glycol-epoetin beta); Roche; For the treatment of anemia associated with chronic renal failure, Approved November 2007 Soliris (eculizumab); Alexion Pharm; For the treatment of paroxysmal nocturnal hemoglobinuria, Approved March 2007
Altabax (retapamulin); GlaxoSmithKline; For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007
AzaSite (azithromycin); InSite Vision; For the treatment of bacterial conjunctivitis, Approved April 2007 Doribax (doripenem); Johnson & Johnson; For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007 Extina (ketoconazole); Stiefel; For the treatment of seborrheic dermatitis, Approved June 2007 Isentress (raltegravir); Merck; For the treatment of HIV-1, Approved October 2007 Selzentry (maraviroc); Pfizer; For the treatment of CCR5-tropic HIV-1, Approved August 2007 Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007 Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Musculoskeletal
Amrix (cyclobenzaprine hydrochloride extended release); Cephalon; For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007 Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007 Reclast (zoledronic acid); Novartis; For the treatment of postmenopausal osteoporosis, Approved August 2007 Reclast (zoledronic acid); Novartis; For the treatment of Paget's disease, Approved April 2007 Somatuline Depot (lanreotide acetate); Beaufour Ipsen; For the treatment of acromegaly, Approved August 2007
Nephrology/Urology
Doribax (doripenem); Johnson & Johnson; For the treatment of intra-abdominal infections and urinary tract infections, Approved October 2007 Mircera (methoxy polyethylene glycol-epoetin beta); Roche; For the treatment of anemia associated with chronic renal failure, Approved November 2007
Renvela (sevelamer carbonate); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved October 2007 Torisel (temsirolimus); Wyeth; For the treatment of renal cell carcinoma, Approved May 2007
Neurology
Amrix (cyclobenzaprine hydrochloride extended release); Cephalon; For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007 Exelon (rivastigmine tartrate); Novartis; For the treatment of Alzheimer's and Parkinson's disease-related dementia, Approved July 2007 Neupro (rotigotine); Schwarz Pharma; For the treatment of Parkinson's disease, Approved May 2007 Nuvigil (armodafinil); Cephalon; For the treatment of excessive sleepiness, Approved June 2007 Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of AttentionDeficit/Hyperactivity Disorder, Approved February 2007
Evamist (estradiol); Vivus; For the treatment of moderate to severe vasomotor symptoms due to menopause, Approved July 2007 Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007 Reclast (zoledronic acid); Novartis; For the treatment of postmenopausal osteoporosis, Approved August 2007
Oncology
Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007 Hycamtin (topotecan hydrochloride); GlaxoSmithKline; For the treatment of small cell lung cancer, Approved October 2007
Ixempra (ixabepilone); Bristol-Myers Squibb; For the treatment of breast cancer, Approved October 2007 Tasigna (nilotinib hydrochloride monohydrate); Novartis; For the treatment of chronic myelogenous leukemia, Approved October 2007 Torisel (temsirolimus); Wyeth; For the treatment of renal cell carcinoma, Approved May 2007 Tykerb (lapatinib); GlaxoSmithKline; For the treatment of breast cancer, Approved March 2007
Ophthalmology
AzaSite (azithromycin); InSite Vision; For the treatment of bacterial conjunctivitis, Approved April 2007
Otolaryngology
Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007 Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Altabax (retapamulin); GlaxoSmithKline; For the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes, Approved April 2007 Supprelin LA (histrelin acetate); Indevus Pharmaceuticals; For the treatment of central precocious puberty, Approved May 2007 Veramyst (fluticasone furoate); GlaxoSmithKline; For the treatment of seasonal and perennial allergic rhinitis, Approved April 2007 Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of AttentionDeficit/Hyperactivity Disorder, Approved February 2007 Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Zingo (lidocaine hydrochloride monohydrate); Anesiva; For local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3 to 18 years of age, Approved August 2007
Vyvanse (Lisdexamfetamine Dimesylate); New River; For the treatment of AttentionDeficit/Hyperactivity Disorder, Approved February 2007
Letairis (ambrisentan); Gilead; For the treatment of pulmonary arterial hypertension, Approved June 2007 Xyzal (levocetirizine dihydrochloride); UCB; For the treatment of seasonal and perennial allergic rhinitis and urticaria, Approved May 2007
Ranexa (ranolazine); CV Therapeutics; For the treatment of chronic angina in patients failing first-line therapy, Approved January 2006
Desonate (desonide); Dow Pharm; For the treatment of atopic dermatitis, Approved October 2006 Verdeso (desonide); Connetics Corporation; For the treatment of atopic dermatitis, Approved September 2006
Endocrinology
Elestrin (estradiol gel); BioSante; For the treatment of vasomotor symptoms associated with menopause, Approved December 2006 Januvia(sitagliptin phosphate); Merck; For the treatment of type II diabetes, Approved October 2006
Gastroenterology
Amitiza (lubiprostone); Sucampo/Takeda; For the treatment of chronic idiopathic constipation, Approved January 2006
Hematology
Dacogen (decitabine); MGI Pharma; For the treatment of both treatment-nave and -experienced Myelodysplastic Syndromes, Approved May 2006
Eraxis (anidulafungin); Pfizer; For the treatment of Candida fungal infections, Approved February 2006 Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine); Merck; For the prevention of cervical cancer associated with human papillomavirus, Approved June 2006 Noxafil (posaconazole); Schering-Plough; For the treatment of fungal infections, Approved in September 2006 Prezista (darunavir); Tibotec; For the treatment of treatment-resistant HIV infections, Approved June 2006 Rotateq (rotavirus vaccine, live oral pentavalent); Merck; For the prevention of gastroenteritis associated with rotavirus infections in infants, Approved February 2006 Tyzeka (telbivudine); Idenix Pharma; For the treatment of hepatitis B virus, Approved October 2006 Veregen (kunecatechins); Medigene; For the treatment of external genital and perianal warts, Approved October 2006
Neurology
Invega (paliperidone); Janssen Pharmaceutica; For the treatment of schizophrenia, Approved December 2006 Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the treatment of alcohol dependence, Approved April 2006
Elestrin (estradiol gel); BioSante; For the treatment of vasomotor symptoms associated with menopause, Approved December 2006
Oncology
Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine); Merck; For the prevention of cervical cancer associated with human papillomavirus, Approved June 2006 Sprycel (dasatinib); Bristol-Myers Squibb; For the treatment of imatinib-resistant chronic myeloid leukemia, Approved June 2006 Sutent (sunitinib); Pfizer; For the treatment of kidney cancer and gastrointestinal stromal tumors, Approved January 2006 Vectibix (panitumumab); Amgen; For the treatment of colorectal cancer, Approved September 2006
Ophthalmology
Lucentis (ranibizumab); Genentech; For the treatment of neovascular (wet) age related macular degeneration, Approved June 2006
Desonate (desonide); Dow Pharm; For the treatment of atopic dermatitis, Approved October 2006 Elaprase (idursulfase); Shire Pharmaceuticals; For the treatmenr of mucopolysaccharidosis II (Hunter Syndrome), Approved July 2006 Myozyme (alglucosidase alfa); Genzyme; For the treatment of Pompe disease (glycogen storage disease type II), Approved April 2006
Chantix (varenicline); Pfizer; For the treatment of nicotine addiction, Approved May 2006 Invega (paliperidone); Janssen Pharmaceutica; For the treatment of schizophrenia, Approved December 2006 Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the treatment of alcohol dependence, Approved April 2006
Brovana (arformoterol tartrate); Sepracor; For the treatment of Chronic Obstructive Pulmonary Disease, Approved in October 2006
Rheumatology
Elaprase (idursulfase); Shire Pharmaceuticals; For the treatmenr of mucopolysaccharidosis II (Hunter Syndrome), Approved July 2006
BiDil (isosorbide dinitrate/hydralazine hydrochloride); NitroMed; For the treatment of heart failure in black patients, Approved June, 2005
Tygacil (tigecycline); Wyeth; For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005
Endocrinology
ACTOplus met (pioglitazone hydrochloride and metformin hydrochloride); Takeda; For the treatment of type 2 diabetes, Approved August of 2005 Byetta (exenatide); Amylin/Eli Lilly; For the adjunctive treatment of Type 2 diabetes mellitus, Approved April, 2005 Increlex (mecasermin); Tercica; For the treatment of growth failure due to Primary IGFD, Approved August 2005 Symlin (pramlintide); Amylin Pharmaceuticals; For the treatment of type I and type II diabetes, Approved March 2005
Gastroenterology
Hematology
Revlimid (lenalidomide); Celgene; For the treatment of low- and intermediate-1-risk myelodysplastic syndromes, Approved December 2005
Aptivus (tipranavir); Boehringer Ingelheim; For the adjunctive treatment of HIV-1 infections, Approved June, 2005 Baraclude (entecavir); Bristol-Myers Squibb; For the treatment of chronic hepatitis B infections with evidence of active viral replication, Approved March, 2005 Tygacil (tigecycline); Wyeth; For the treatment of complicated skin and skin structure and intra-abdominal infections and bacterial pneumonia, Approved 2005
Musculoskeletal
Boniva (ibandronate); Roche / GlaxoSmithKline; For the treatment and prevention of osteoporosis, Approved May, 2003 -- UPDATED: NEW FORMULATION APPROVED MARCH, 2005 Naglazyme (galsulfase); BioMarin Pharmaceuticals; For the treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome), Approved May 2005
Nephrology/Urology
Vaprisol (conivaptan); Astellas; For the treatment of euvolemic hyponatremia, Approved December 2005
Neurology
Rozerem (ramelteon); Takeda; For the treatment of sleep-onset insomnia, Approved July, 2005 Tysabri (natalizumab); Elan Pharmaceuticals / Biogen Idec; For the treatment of relapsing forms of multiple sclerosis, Approved November 2004 -- Updated: Suspended February 2005-Updated: sBLA
Oncology
Arranon (nelarabine); GlaxoSmithKline; For the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, Approved October 2005 Nexavar (sorafenib); Bayer/Onyx; For the Treatment of Renal Cell Carcinoma, Approved December 2005
Rheumatology
Orencia (abatacept); Bristol-Myers Squibb; For the Treatment of Rheumatoid Arthritis, Approved December 2005
Caduet (amlodipine/atorvastatin ); Pfizer; For the treatment of hypertension, chronic stable angina and vasospastic angina, Approved January 2004
Gastroenterology
Avastin (bevacizumab); Genentech; For the treatment of metastatic carcinoma of the colon or rectum, Approved February 2004
Erbitux (cetuximab); Imclone, Bristol-Myers Squibb; For the treatment of EGFR-expressing, metastatic colorectal cancer, Approved February 2004
Hematology
Vidaza (azacitidine); Pharmion Corporation; For the treatment of several myelodysplastic syndrome subtypes including refractory and chronic myelomonocytic leukemias, Approved May 2004
Ketek (telithromycin); Sanofi-aventis; For the treatment of infections caused by bronchitis, bacterial sinusitis and Community-acquired pneumonia., Approved April 2004 Tindamax, tinidazole; Presutti Laboratories; For the treatment of microbial infections, including trichomoniasis, giardiasis, and amebiasis, Approved May, 2004 Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of Travelers' diarrhea caused by noninvasive strains of Escherichia coli, Approved May 2004
Musculoskeletal
Vioxx (rofecoxib); Merck; For the treatment of rheumatoid arthritis, Approved April 2002 -UPDATED: WITHDRAWN OCTOBER 2004
Nephrology/Urology
Fosrenol, lanthanum carbonate; Shire Pharmaceuticals; For the treatment of hyperphosphatemia related to kidney dysfunction, Approved October, 2004 Sanctura (trospium chloride); Indevus Pharmaceuticals; For the treatment of overactive bladder with symptoms of urge urinary incontinence, Approved May, 2004 Sensipar (cinacalcet); Amgen; For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients, Approved March 2004 Vesicare (solifenacin succinate); Yamanouchi, GlaxoSmithKline; For the treatment of overactive bladder with symptoms of urge urinary incontinence, Approved November, 2004
Neurology
Apokyn (apomorphine hydrochloride); Mylan Bertek Pharmaceuticals; For the treatment of acute, intermittent hypomobility episodes associated with advanced Parkinsons disease, Approved April, 2004 Lunesta (eszopiclone); Sepracor; For the treatment of insomnia and sleep maintenance, Approved December 2004 Lyrica (pregabalin); Pfizer; For the treatment of pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, Approved December 2004
EstroGel (estradiol gel 0.06%); Solvay Pharmaceuticals; For the treatment of vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, Approved April 2004
Oncology
Alimta (pemetrexed for injection); Eli Lilly; For the treatment of malignant pleural mesothelioma, Approved February 2004 Avastin (bevacizumab); Genentech; For the treatment of metastatic carcinoma of the colon or rectum, Approved February 2004 Clolar (clofarabine); Genzyme; For the treatment of acute lymphoblastic leukemia in pediatric patients, Approved December, 2004 Erbitux (cetuximab); Imclone, Bristol-Myers Squibb; For the treatment of EGFR-expressing, metastatic colorectal cancer, Approved February 2004 Sensipar (cinacalcet); Amgen; For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients, Approved March 2004 Tarceva (erlotinib, OSI 774); Genentech, OSI Pharmaceuticals; For the treatment of advanced refractory metastatic non-small cell lung cancer, Approved November, 2004
Ophthalmology
Macugen (pegaptanib); Pfizer / Eyetech Pharmaceuticals; For the treatment of wet age-related macular degeneration., Approved December 2004
Campral (acamprosate calcium); Forest Laboratories; For the treatment of alcohol dependence and the maintenance of alcohol abstinence, Approved August, 2004
Cymbalta (duloxetine); Eli Lilly; For the treatment of major depressive disorder, Approved August 2004
Ketek (telithromycin); Sanofi-aventis; For the treatment of infections caused by bronchitis, bacterial sinusitis and Community-acquired pneumonia., Approved April 2004 Spiriva HandiHaler (tiotropium bromide); Boehringer Ingelheim; For the treatment of bronchospasm associated with chronic obstructive pulmonary disease, Approved February 2004
Rheumatology
Vioxx (rofecoxib); Merck; For the treatment of rheumatoid arthritis, Approved April 2002 -UPDATED: WITHDRAWN OCTOBER 2004
2003
Crestor (rosuvastatin calcium); AstraZeneca; For the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia, Approved August 2003 Levitra (vardenafil); Bayer, GlaxoSmithKline; For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003
Amevive (alefacept); Biogen IDEC; For moderate to severe chronic plaque psoriasis., Approved January 2003 Finacea (azelaic acid) Gel, 15%; Berlex Laboratories; Gel formulation for the treatment of rosacea., January 2003
Endocrinology
Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003
Fabrazyme (agalsidase beta); Genzyme; For the treatment of Fabry disease in adult patients, Approved April 2003 Somavert (pegvisomant); Pharmacia; Injectable formulation for the treatment of acromegaly, Approved March 2003
Gastroenterology
Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare; For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, Approved August 2003 Emend (aprepitant); Merck; For the treatment of nausea and vomiting associated with chemotherapy, Approved March 2003 Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals; For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency., Approved March 2003
Hematology
Bexxar; Corixa; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse, Approved June 2003 Levitra (vardenafil); Bayer, GlaxoSmithKline; For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003 Reyataz (atazanavir sulfate); Bristol-Myers Squibb; For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003 Zemaira (alpha1-proteinase inhibitor); Aventis Behring; For the treatment of alpha1-proteinase inhibitor deficiency (Alpha1) and emphysema, Approved July 2003
Amevive (alefacept); Biogen IDEC; For moderate to severe chronic plaque psoriasis., Approved January 2003 FluMist ( Influenza Virus Vaccine); MedImmune; For the prevention of disease caused by influenza A and B viruses, Approved June 2003 Fuzeon (enfuvirtide); Trimeris, Roche; For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved March 2003 Lexiva (fosamprenavir calcium); GlaxoSmithKline; For the treatment of HIV infection in adults in combination with other antiretroviral agents., Approved October 2003 Reyataz (atazanavir sulfate); Bristol-Myers Squibb; For the treatment of HIV-1 infection in combination with other antiretroviral agents, Approved July 2003
Musculoskeletal
Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003 Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003 Somavert (pegvisomant); Pharmacia; Injectable formulation for the treatment of acromegaly, Approved March 2003 Velcade (bortezomib); Millennium Pharmaceuticals; Injectable agent for the treatment of multiple myeloma patients who have received at least two prior therapies., Approved May 2003
Nephrology/Urology
Fabrazyme (agalsidase beta); Genzyme; For the treatment of Fabry disease in adult patients, Approved April 2003 Oxytrol (oxybutynin transdermal system); Watson Pharmaceuticals; For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency., Approved March 2003 UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis; For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003
Neurology
Cialis (tadalafil); Eli Lilly; Oral agent for the treatment for erectile dysfunction, Approved December 2003 Levitra (vardenafil); Bayer, GlaxoSmithKline; For the treatment of erectile dysfunction related to sexual activity in men, Approved September 2003 Namenda (memantine HCl); Forest Laboratories; For the treatment of moderate to severe dementia of the Alzheimers type., Approved October 2003
Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003 Seasonale, Lo Seasonale, Seasonique (ethinylestradiol + levonorgestrel); Duramed; For the prevention of contraception, Approved September 2003
Oncology
Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare; For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, Approved August 2003 Bexxar; Corixa; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse, Approved June 2003 Emend (aprepitant); Merck; For the treatment of nausea and vomiting associated with chemotherapy, Approved March 2003 Iressa (gefitinib); AstraZeneca; For the second-line treatment of non-small-cell lung cancer, Approved May 2003 Plenaxis (abarelix for injectable suspension); Praecis Pharmaceuticals; For treatment of advanced prostate cancer, Approved December 2003 Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003 UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis; For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003 Velcade (bortezomib); Millennium Pharmaceuticals; Injectable agent for the treatment of multiple myeloma patients who have received at least two prior therapies., Approved May 2003
Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003
Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003 Iressa (gefitinib); AstraZeneca; For the second-line treatment of non-small-cell lung cancer, Approved May 2003 Xolair (omalizumab); Genentech; For the treatment of asthma, Approved June 2003 Zemaira (alpha1-proteinase inhibitor); Aventis Behring; For the treatment of alpha1-proteinase inhibitor deficiency (Alpha1) and emphysema, Approved July 2003
2002
Altocor (lovastatin) Extended-Release Tablets; Andrx; Oral tablets for the adjuctive treatment of hypercholesterolemia, Approved June 2002 Benicar; Daiichi Sankyo; Oral tablet for the treatment of hypertension, Approved April 2002 Imagent (perflexane lipid microspheres); Alliance Pharmaceutical; Ultrasound contrast agent for improved imaging of the heart, Approved June 2002 Inspra (eplerenone tablets); Pharmacia; Oral tablets for the treatment of high blood pressure., Approved September 2002 Plavix (clopidogrel bisulfate); Sanofi-aventis; For the treatment of acute coronary syndrome, Approved February 2002 Remodulin (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms, Approved May 2002
Botox Cosmetic (botulinum toxin type A); Allergan; For the temporary improvement in the appearance of glabellar lines (brow furrow), Approved April 2002
Endocrinology
Avandamet (rosiglitazone maleate and metformin HCl); GlaxoSmithKline; For improvement of glycemic control in type 2 diabetes patients, Approved October 2002 Benicar; Daiichi Sankyo; Oral tablet for the treatment of hypertension, Approved April 2002 Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals; Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002 Forteo (teriparatide); Eli Lilly; For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002 Levo-T (levothyroxine sodium); Mova Pharmaceutical; Indicated for the treatment of hypothyroidism and the suppression of thyroid stimulating hormone, Approved March 2002 Metaglip (glipizide/metformin HCl); Bristol-Myers Squibb; Oral tablets for the treatment of type 2 diabetes., Approved October 2002 Novothyrox (levothyroxine sodium); Genpharm; For the treatment of hypothyroidism and suppression of thyroidstimulating hormone, Approved May 2002 Synthroid (levothyroxine sodium); Abbott Laboratories; For replacement or supplemental therapy for hypothyroidism and pituitary thyroid stimulating hormone suppression, Approved July 2002
Testim; Auxilium Pharmaceuticals; External cream for the treatment of male hormone deficiency., Approved October 2002
Gastroenterology
Aciphex (rabeprazole sodium); Elan Pharmaceuticals; For the treatment of symptomatic gastroesophageal reflux disease, Approved February 2002 Alinia (nitazoxanide); Romark Laboratories; For the treatment Diarrhea caused by Cryptosporidium and Giardia in children., December 2002 Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); Sanofi-aventis; For the treatment of colon or rectum carcinomas, Approved August 2002 Gleevec (imatinib mesylate); Novartis; For the treatment of gastrointestinal stromal tumors (GISTs), Approved February 2002 Hepsera (adefovir dipivoxil); Gilead; For the treatment of chronic hepatitis B in adults with evidence of active viral replication, Approved September 2002 Orfadin (nitisinone); Orphan Pharmaceuticals; Capsules for the treatment of hereditary tyrosinemia type I, Approved January 2002 Pegasys (peginterferon alfa-2a); Roche; For the treatment of chronic hepatitis C who have compensated liver disease, Approved October 2002 Protonix (pantoprazole sodium) Delayed Release Tablets; Wyeth; Oral tablets for the treatment of gastroesophageal and pathological hypersecretory conditions, Approved April 2002 SecreFlo (secretin); Repligen; To aid in the diagnosis of pancreatic dysfunction and gastrinoma, Approved April 2002 Zelnorm (tegaserod maleate) Tablets; Novartis; For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation, Approved July 2002 Zelnorm (tegaserod maleate) Tablets; Novartis; For the short-term treatment of irritable bowel syndrome in women whose primary bowel symptom is constipation, Approved July 2002
Hematology
Neulasta; Amgen; Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy, Approved January 2002
Alinia (nitazoxanide); Romark Laboratories; For the treatment Diarrhea caused by Cryptosporidium and Giardia in children., December 2002 Clarinex; Schering-Plough; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria, Approved February 2002 Daptacel; Sanofi Pasteur; Pediatric vaccine for immunization against diptheria, tetanus and pertussis, Approved May 2002 Fluzone Preservative-free; Sanofi Pasteur; Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants, Approved September 2002 Hepsera (adefovir dipivoxil); Gilead; For the treatment of chronic hepatitis B in adults with evidence of active viral replication, Approved September 2002 Pediarix Vaccine; GlaxoSmithKline; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002 Pegasys (peginterferon alfa-2a); Roche; For the treatment of chronic hepatitis C who have compensated liver disease, Approved October 2002 Restasis (cyclosporine ophthalmic emulsion); Allergan; For the treatment of low tear production., December 2002 Sustiva; Bristol-Myers Squibb; Once-daily oral tablet for the the treatment of HIV infection, Approved February 2002 Vfend (voriconazole); Pfizer; For the treatment of fungal infections, Approved May 2002
Musculoskeletal
Alora; Watson Pharmaceuticals; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms, Approved April 2002 Avinza (morphine sulfate); Elan Pharmaceuticals; Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy, Approved March 2002 Forteo (teriparatide); Eli Lilly; For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002 Remicade (infliximab); Centocor; Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002 Testim; Auxilium Pharmaceuticals; External cream for the treatment of male hormone deficiency., Approved October 2002 Vivelle-Dot (estradiol transdermal system); Novartis; For the prevention of post-menopausal osteoporosis, Approved May 2002
Nephrology/Urology
Eligard (leuprolide acetate); Atrix Laboratories; For the palliative treatment of advanced prostate cancer, Approved January 2002 Mesnex; Bristol-Myers Squibb, Baxter Healthcare; Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide), Approved March 2002
Neurology
Avinza (morphine sulfate); Elan Pharmaceuticals; Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy, Approved March 2002 Neurontin (gabapentin); Pfizer; Oral treatment for the management of post-herpetic neuralgia (PHN), Approved May 2002 Rebif (interferon beta-1a); Serono Laboratories; Subcutaneous injection for the treatment of relapsing forms of multiple sclerosis, Approved March 2002 Relpax (eletriptan hydrobromide); Pfizer; For the acute treatment of migraine headaches, Approved December 2002 Strattera (atomoxetine HCl); Eli Lilly; For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002 Xyrem (sodium oxybate); Orphan Medical; For the treatment of cataplexy, a sudden loss of muscle tone, associated with narcolepsy, Approved July 2002
Alora; Watson Pharmaceuticals; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms, Approved April 2002 Bravelle (urofollitropin for injection, purified); Ferring Pharmaceuticals; Human-derived follicle-stimulating hormone (hFSH) for use in ovulation induction for the treatment of infertility., Approved May 2002 Forteo (teriparatide); Eli Lilly; For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002 Vivelle-Dot (estradiol transdermal system); Novartis; For the prevention of post-menopausal osteoporosis, Approved May 2002 Zoloft (sertraline HCl); Pfizer; Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD), Approved May 2002
Oncology
Eligard (leuprolide acetate); Atrix Laboratories; For the palliative treatment of advanced prostate cancer, Approved January 2002 Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); Sanofi-aventis; For the treatment of colon or rectum carcinomas, Approved August 2002 Faslodex (fulvestrant); AstraZeneca; For the treatment of hormone receptor positive metastatic breast cancer, Approved April 2002 Gleevec (imatinib mesylate); Novartis; For the treatment of gastrointestinal stromal tumors (GISTs), Approved February 2002 Neulasta; Amgen; Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy, Approved January 2002 SecreFlo (secretin); Repligen; To aid in the diagnosis of pancreatic dysfunction and gastrinoma, Approved April 2002 Zevalin (ibritumomab tiuxetan); Biogen IDEC; For the treatment of non-Hodgkin's lymphoma, Approved February 2002 Zometa (zoledronic acid); Novartis; For the treatment of multiple myeloma and bone metastases from solid tumors, Approved February 2002
Ophthalmology
Restasis (cyclosporine ophthalmic emulsion); Allergan; For the treatment of low tear production., December 2002
Alinia (nitazoxanide); Romark Laboratories; For the treatment Diarrhea caused by Cryptosporidium and Giardia in children., December 2002 Daptacel; Sanofi Pasteur; Pediatric vaccine for immunization against diptheria, tetanus and pertussis, Approved May 2002 Fluzone Preservative-free; Sanofi Pasteur; Preservative free, pediatric dose, influenza virus vaccine for the immunization of infants, Approved September 2002 Orfadin (nitisinone); Orphan Pharmaceuticals; Capsules for the treatment of hereditary tyrosinemia type I, Approved January 2002 Pediarix Vaccine; GlaxoSmithKline; For the prevention of diphtheria, tetanus, pertussi, polio and hepatitis B in children 6 weeks to 7 years old., Approved December 2002 Qvar (beclomethasone dipropionate); Ivax; For the treatment of asthma, Approved May 2002
Ritalin LA (methylphenidate HCl); Novartis; Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD), Approved June 2002 Strattera (atomoxetine HCl); Eli Lilly; For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002
Mesnex; Bristol-Myers Squibb, Baxter Healthcare; Oral tablet to inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide), Approved March 2002 Subutex/Suboxone (buprenorphine/naloxone); Reckitt Benckiser; Oral tablets for the treatment of opiate dependence, Approved October 2002
Abilify (aripiprazole); Bristol-Myers Squibb, Otsuka America Pharmaceutical; Oral drug for the treatment of schizophrenia, Approved November 2002 Geodon (ziprasidone mesylate); Pfizer; To control agitated behavior and psychotic symptoms in schizophrenia patients, Approved June 2002 Lexapro (escitalopram oxalate); Forest Laboratories; An orally administered selective serotonin reuptake inhibitor useful for the treatment for major depressive disorder, Approved August 2002 Paxil CR (paroxetine hydrochloride); GlaxoSmithKline; Oral tablet for the treatment of depression and panic disorder, Approved February 2002 Ritalin LA (methylphenidate HCl); Novartis; Oral capsules for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD), Approved June 2002 Strattera (atomoxetine HCl); Eli Lilly; For the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults., December 2002 Subutex/Suboxone (buprenorphine/naloxone); Reckitt Benckiser; Oral tablets for the treatment of opiate dependence, Approved October 2002 Zoloft (sertraline HCl); Pfizer; Oral tablets for the treatment of premenstrual dysphoric mood disorder (PMDD), Approved May 2002
Clarinex; Schering-Plough; Once-daily oral tablet for the treatment of allergic rhinitis and chronic ideopathic urticaria, Approved February 2002 Qvar (beclomethasone dipropionate); Ivax; For the treatment of asthma, Approved May 2002 Remodulin (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms, Approved May 2002 Xopenex; Sepracor; Inhaled solution for treatment of reversible obstructive airway disease, Approved February 2002
Rheumatology
Enbrel (etanercept); Immunex; For the treatment of psoriatic arthritis, Approved January 2002 Humira (adalimumab); Abbott Laboratories; For the treatment of moderately to severely active rheumatoid arthritis, Approved December 2002 Remicade (infliximab); Centocor; Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002
2001
Advicor (extended-release niacin/lovastatin); Kos Pharmaceuticals; For the treatment of cholesterol disorders, Approved December 2001 Diovan (valsartan); Novartis; Oral capsules and tablets for the treatment of hypertension, Approved January 1997 (capsules); July 2001 (tablets) Natrecor (nesiritide); Scios; For the treatment of patients with acutely decompensated congestive heart failure, Approved August 2001 Teveten (eprosartan mesylate plus hydrochlorothiazide); Unimed Pharmaceuticals; Tablets for the treatment of hypertension, Approved November 2001 Tricor (fenofibrate); Abbott Laboratories; For the treatment of primary hypercholesterolemia, mixed lipidemia and hypertriglyceridemia, Approved September 2001
Dental/Maxillofacial Surgery
Arestin (minocycline hydrochloride); OraPharma; For treatment of adult periodontitis, Approved February 2001
Periostat (doxycycline hyclate); CollaGenex Pharmaceuticals; Oral tablet for adjunctive treatment of adult periodontitis, Approved February 2001
Elidel; Novartis; Topical cream for the treatment of atopic dermatitis, Approved December 2001 Estrostep (norethindrone acetate and ethinyl estradiol); Pfizer; For the treatment of moderate acne vulgaris, Approved July 2001 Finevin; Berlex Laboratories; Topical cream for the treatment of mild to moderate inflammatory acne vulgaris, Approved May 2001 Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001 Lamisil Solution, 1%; Novartis; Topical treatment for tinea (pityriasis) versicolor, althete's foot, jock itch, and ringworm, Approved March 2001
Endocrinology
Campath; Berlex Laboratories; Injectable treatment of B-cell chronic lymphocytic leukemia, Approved May 2001 Diovan (valsartan); Novartis; Oral capsules and tablets for the treatment of hypertension, Approved January 1997 (capsules); July 2001 (tablets) Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001 Genotropin (somatropin) injection; Pharmacia; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001 Gleevec (imatinib mesylate); Novartis; Oral therapy for the treatment of chronic myeloid leukemia, Approved May 2001 Levoxyl; Jones Pharma; Oral therapy for the treatment of hypothyroidism and suppression of thyroid-stimulating hormone (TSH), Approved May 2001 Natrecor (nesiritide); Scios; For the treatment of patients with acutely decompensated congestive heart failure, Approved August 2001 Novolog Mix 70/30; Novo Nordisk; Subcutaneous injection for the control of hyperglycemia, associated with type 1 and 2 diabetes, Approved November 2001 Prozac Weekly (fluoxetine HCl); Eli Lilly; For the treatment of depression, Approved February 2001
Remeron SolTab (mirtazapine); Organon; Orally disintegrating tablet for the treatment of depression, Approved January 2001 Remicade (infliximab); Centocor; For inhibiting the progression of structural damage in patients with rheumatoid arthritis, Approved January 2001 Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001 Yasmin (drospirenone/ethinyl estradiol); Berlex Laboratories; Oral contraceptive, Approved May 2001 Zometa (zoledronic acid); Novartis; For the treatment of hypercalcemia of malignancy, Approved August 2001
Gastroenterology
Canasa (mesalamine); Axcan; For the treatment of active ulcerative proctitis, Approved January 2001 Entocort EC (budesonide); AstraZeneca; Capsules for the treatment of mild-to-moderate, active Crohn's disease, Approved October 2001 Nexium (esomeprazole magnesium); AstraZeneca; For the eradication of Helicobacter pylori, the healing of erosive esophagitis, and the treatment of symptomatic GERD, Approved February 2001 Protonix (pantoprazole sodium) Intravenous Formulation; Wyeth; For the short-term treatment of gastroesophageal reflux disease, Approved March 2001 Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001 Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001
Hematology
Arixtra; Organon, Sanofi-Synthelabo; Injectable solution for the prevention of deep vein thrombosis, Approved December 2001
Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001 Cancidas; Merck; Intravenous infusion for the treatment of invasive aspergillosis, Approved January 2001 Peg-Intron (peginterferon alfa-2b); Schering-Plough; For the treatment of chronic hepatitis C, Approved January 2001 Rebetol (ribavirin); Schering-Plough; For the treatment of chronic hepatitis C, Approved July 2001
Spectracef; TAP Pharmaceuticals; Oral tablets for the treatment of mild to moderate bacterial infections, Approved August 2001 Twinrix; GlaxoSmithKline; For the prevention of hepatitis A and B, Approved May 2001 Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March 2001 Viread (tenofovir disoproxil fumarate); Gilead; Once-daily oral tablet for the treatment of human immunodeficiency virus (HIV) infection, Approved October 2001 Xigris (drotrecogin alfa [activated]); Eli Lilly; For the treatment of severe sepsis, Approved November 2001
Musculoskeletal
Genotropin (somatropin) injection; Pharmacia; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001 Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001 Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January 2001
Nephrology/Urology
dutasteride; GlaxoSmithKline; For the treatment of symptomatic benign prostatic hyperplasia, Approved November 2001 Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001 PhosLo; Braintree Laboratories; Oral capsules and gelcaps for the control of hyperphosphatemia in end stage renal failure, Approved April 2001 Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001
Neurology
Axert (almotriptan malate) tablets; Pharmacia; For the treatment of migraine attacks, Approved May 2001 Bayer Extra Strength Asprin; Bayer; Oral treatment for mild to moderate migraine pain, Approved October 2001 Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001
Frova (frovatriptan succinate); Elan Pharmaceuticals; Tablets for the acute treatment of migraine attacks, Approved November 2001 Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001 Reminyl (galantamine hydrobromide); Janssen Pharmaceutica; For the treatment of mild to moderate dementia of the Alzheimer's type, Approved February 2001 Ultracet (acetaminophen and tramadol HCl); Ortho-McNeil Pharmaceutical; For the short-term management of acute pain, Approved August 2001 Zomig (zolmitriptan); AstraZeneca; Orally disintegrating tablet for the treatment of acute migraine in adults, Approved February 2001
Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved November 2001 Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001 Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001 Monistat 3 (miconazole nitrate); Advanced Care Products; Emulsion, cream for the treatment of vaginal yeast infections, Approved February 2001 NuvaRing; Organon; Monthly vaginal ring for birth control, Approved October 2001 Ortho Evra; Ortho-McNeil Pharmaceutical; Transdermal patch for contraception, Approved November 2001 Yasmin (drospirenone/ethinyl estradiol); Berlex Laboratories; Oral contraceptive, Approved May 2001
Oncology
Campath; Berlex Laboratories; Injectable treatment of B-cell chronic lymphocytic leukemia, Approved May 2001 Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001 Gleevec (imatinib mesylate); Novartis; Oral therapy for the treatment of chronic myeloid leukemia, Approved May 2001
Kytril (granisetron) solution; Roche; For the prevention of nausea and vomiting associated with cancer therapy, Approved June 2001 Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001 Xeloda; Roche; Oral chemotherapy for the treatment of metastatic colorectal cancer, Approved May 2001 Zometa (zoledronic acid); Novartis; For the treatment of hypercalcemia of malignancy, Approved August 2001
Ophthalmology
Lumigan (bimatoprost ophthalmic solution); Allergan; For the reduction of intraocular pressure in patients with openangle glaucoma or ocular hypertension, Approved March 2001 Travatan (travoprost ophthalmic solution); Alcon; For the reduction of elevated intraocular pressure in patients with openangle glaucoma or ocular hypertension, Approved March 2001 Valcyte (valganciclovir HCl); Roche; For the treatment of cytomegalovirus retinitis in patients with AIDS, Approved March 2001
Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD), Approved October 2001 Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001 Genotropin (somatropin) injection; Pharmacia; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001 Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001 NasalCrom Nasal Spray; Pharmacia; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved April 2001
Adderall XR; Shire Pharmaceuticals; Once-daily medication for the treatment of attention deficit/hyperactivity disorder (ADHD), Approved October 2001
Focalin (dexmethylphenidate HCl); Celgene; For the treatment of attention deficit hyperactivity disorder (ADHD), Approved November 2001 Metadate CD; Celltech Pharmaceuticals; Oral capsules for the treatment of attention deficit hyperactivity disorder, Approved April 2001 Prozac Weekly (fluoxetine HCl); Eli Lilly; For the treatment of depression, Approved February 2001 Remeron SolTab (mirtazapine); Organon; Orally disintegrating tablet for the treatment of depression, Approved January 2001 Ziprasidone (ziprasidone hydrochloride); Pfizer; Oral capsule for the treatment of schizophrenia, Approved February 2001
Avelox I.V. (moxifloxacin hydrochloride); Bayer; Injectable antibacterial agent for adults with susceptible strains of bacterial infections, Approved November 2001 DuoNeb (albuterol sulfate and ipratropium bromide); Dey Laboratories; For the treatment of bronchospasm associated with COPD, Approved March 2001 Foradil Aerolizer (formoterol fumarate inhalation powder); Novartis; Bronchodilator for COPD, asthma and bronchospasm, Approved February 2001 (asthma, bronchospasm); September 2001 (COPD) Invanz; Merck; Once-daily injectable treatment for bacterial infections, Approved November 2001 NasalCrom Nasal Spray; Pharmacia; Over-the-counter nasal spray for treatment of all nasal allergy symptoms, Approved April 2001 Tavist (clemastine fumarate); Novartis; Oral tablet for temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold, Approved March 2001 Tracleer (bosentan); Actelion; For the treatment of pulmonary arterial hypertension, Approved November 2001 Ventolin HFA (albuterol sulfate inhalation aerosol); GlaxoSmithKline; For the treatment or prevention of bronchospasm, Approved April 2001
Rheumatology
Bextra; Pharmacia, Pfizer; Oral tablet for the treatment of osteoarthritis, rheumatoid arthritis and menstrual pain, Approved November 2001 Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001
Remicade (infliximab); Centocor; For inhibiting the progression of structural damage in patients with rheumatoid arthritis, Approved January 2001 Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January 2001
2000
Angiomax (bivalirudin); The Medicines Company; For patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), Approved December 2000 Argatroban Injection; Texas Biotechnology Corporation, SmithKline Beecham; Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia., Approved June 2000 Atacand (candesartan cilexetil); AstraZeneca; For the treatment of hypertension, Approved September 2000 Betapace AF Tablet; Berlex Laboratories; For treatment of the irregular heartbeats in patients with atrial fibrillation, Approved February 2000 Diltiazem HCL, Extended-Release Capsules; Biovail Laboratories; For the reduction of high blood pressure, Approved January 2000 Innohep (tinzaparin sodium) injectable; DuPont Merck Pharmaceutical Company; For the treatment of acute symptomatic deep vein thrombosis, Approved July 2000 Lescol XL (fluvastatin sodium) tablet, extended release; Novartis; For the use as an adjunct to diet to reduce elevated total cholesterol, Approved October 2000 Micardis HCT (telmisartan and hydrochlorothiazide); Boehringer Ingelheim; For the treatment of hypertension, Approved November 2000 Nitrostat (nitroglycerin) Tablets; Parke-Davis; For the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease., Approved May 2000
Benzamycin (erythromycin 3%-benzoyl peroxide 5% topical gel); Dermik Laboratories; For the topical treatment of acne vulgaris, Approved November 2000 Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000 Chloraprep (chlorhexidine gluconate); MEDI FLEX HOSP PRODUCTS; For use as a patient preoperative skin preparation, Approved July 2000 Clindamycin phosphate topical gel; Target Research Associates; For once a day treatment of acne vulgaris, Approved November 2000 Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot, jock itch and ringworm, Approved March 2000 Protopic (tacrolimus) ointment; Fujisawa Healthcare; For short-term and intermittent longterm treatment of moderate to severe atopic dermatitis, Approved December 2000 Skin Exposure Reduction Paste Against Chemical Warfare Agents (SERPACWA); U.S. Army Medical Research, Material Command; To reduce absorption of chemical warfare agents through the skin, Approved February 2000
Endocrinology
Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause, Approved April 2000 AndroGel testosterone gel; Unimed Pharmaceuticals; For testosterone replacement therapy in males with testosterone deficiency, Approved February 2000 Atacand (candesartan cilexetil); AstraZeneca; For the treatment of hypertension, Approved September 2000 Cetrotide; Asta Medica; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation, Approved August 2000 Diltiazem HCL, Extended-Release Capsules; Biovail Laboratories; For the reduction of high blood pressure, Approved January 2000
Hectorol (Doxercalciferol) Injection; Bone Care International; To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis, Approved April 2000 Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia, Approved April 2000 Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For the treatment of type I and type II diabetes mellitus in adults and pediatrics, Approved April 2000 Lescol XL (fluvastatin sodium) tablet, extended release; Novartis; For the use as an adjunct to diet to reduce elevated total cholesterol, Approved October 2000 Micardis HCT (telmisartan and hydrochlorothiazide); Boehringer Ingelheim; For the treatment of hypertension, Approved November 2000 Mirena (levonorgestrel-releasing intrauterine system); Berlex Laboratories; Hormonereleasing system for intrauterine contraception, Approved December 2000 NovoLog (insulin aspart); Novo Nordisk; An insulin analogue for the treatment of diabetes mellitus., Approved June 2000 Ovidrel (gonadotropin, chorionic human recombinant); Serono Laboratories; For the induction of final follicular maturation and early luteinization in infertile women, Approved September 2000 Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000 Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate cancer, Approved March 2000 Vivelle (estradiol transdermal system); Novartis; For the prevention of postmenopausal osteoporosis, Approved August 2000
Gastroenterology
Colazal (balsalazide disodium); Salix Pharmaceuticals; Mild to moderately active ulcerative colitis, Approved July 2000
Lotronex (alosetron HCL) Tablets; GlaxoSmithKline; Indicated for Irritable Bowel Syndrome (IBS) in females with diarrhea-predominant IBS, Approved February 2000 Pepcid Complete; Merck; For use in the relief of heartburn associated with acid indigestion and sour stomach, Approved October 2000 Protonix (pantoprazole sodium) Delayed-Release Tablets; Wyeth; For treatment of erosive esophagitis, Approved February 2000 Visicol Tablet; Inkine Pharmaceutical; For cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older, Approved September 2000
Hematology
Argatroban Injection; Texas Biotechnology Corporation, SmithKline Beecham; Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia., Approved June 2000 Innohep (tinzaparin sodium) injectable; DuPont Merck Pharmaceutical Company; For the treatment of acute symptomatic deep vein thrombosis, Approved July 2000 Kogenate FS (Antihemophilic Factor Recombinant); Bayer; For the treatment of hemophilia A, Approved June 2000 Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000 Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000
ABREVA (docosanol); AVANIR PHARMACEUTICALS; Cold sore/fever blister, Approved July 2000 Biaxin XL (clarithromycin extended-release tablets); Abbott Laboratories; For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis, Approved March 2000 Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000
Children's Motrin Cold; McNeil Consumer Products; For temporary relief of the common cold, Approved August 2000 Evoxac; SnowBrand Pharmaceuticals; For the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome, Approved January 2000 Kaletra Capsules and Oral Solution; Abbott Laboratories; For the treatment of HIV-1 infection, Approved September 2000 Lamisil (terbinafine hydrochloride) Solution, 1%; Novartis; For the treatment of athlete's foot, jock itch and ringworm, Approved March 2000 Lotrisone (clotrimazole/betamethasone diproprionate) lotion; Schering-Plough; For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis, Approved December 2000 Malarone (atovaquone; proguanil hydrochloride) Tablet; GlaxoSmithKline; For the treatment and prevention of Plasmodium falciparum malaria, Approved July 2000 Rapamune (sirolimus) Tablets; Wyeth; For treatment of kidney rejection, Approved August 2000 Rid Mousse; Soltec Research; For the treatment of head, pubic (crab), and body lice, Approved March 2000 Tri-Nasal Spray (triamcinolone acetonide spray); Muro Pharmaceutical; For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older, Approved February 2000 Trivagizole 3 (clotrimazole) Vaginal Cream; Taro Pharmaceuticals; For the treatment of vaginal yeast infections, Approved April 2000 Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet; GlaxoSmithKline; For the treatment of HIV-1 infection, Approved November 2000
Musculoskeletal
Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause, Approved April 2000
Mobic (meloxicam) Tablets; Boehringer Ingelheim; For relief of the signs and symptoms of osteoarthritis, Approved April 2000 Myobloc; Elan Pharmaceuticals; Injectable solution for the treatment of abnormal head position and neck pain associated with cervical dystonia, Approved December 2000
Nephrology/Urology
Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000 Detrol LA (tolterodine tartrate); Pharmacia & Upjohn; For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency, Approved December 2000 Hectorol (Doxercalciferol) Injection; Bone Care International; To reduce iPTH levels in management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis, Approved April 2000 Rapamune (sirolimus) Tablets; Wyeth; For treatment of kidney rejection, Approved August 2000 Renagel (sevelamer hydrochloride); GelTex Pharmaceuticals; For the reduction of serum phosphorus in patients with end-stage renal disease (ESRD), Approved July 2000 Renagel (sevelamer hydrochloride); Genzyme; For the control of serum phosphorus in patients with chronic kidney disease on dialysis, Approved July of 2000 Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000 Venofer (iron sucrose injection); Luitpold Pharmaceuticals; For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis, Approved November 2000 Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate cancer, Approved March 2000
Neurology
Depakote ER (divalproex sodium); Abbott Laboratories; For the prophylaxis (prevention) of migraine headaches in adults, Approved August 2000
Exelon (rivastigmine tartrate); Novartis; Indicated for the treatment of mild to moderate dementia of the Alzheimer's type, Approved April 2000 Myobloc; Elan Pharmaceuticals; Injectable solution for the treatment of abnormal head position and neck pain associated with cervical dystonia, Approved December 2000 Neurontin (gabapentin) oral solution; Parke-Davis; For the treatment of partial seizures in pediatric patients three years of age and older, Approved October 2000 Neurontin (gabapentin) oral solution; Parke-Davis; Treatment of partial seizures in adults with epilepsy, Approved March 2000 Novantrone (mitoxantrone hydrochloride); Immunex; For reducing neurologic disability and/or the frequency of clinical relapses in patients with multiple sclerosis, Approved October 2000 Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults), Approved January 2000 Zonegran (zonisamide) Capsules; Dainippon Pharmaceutical; Adjunctive therapy for treatment of partial seizures in adults with epilepsy, Approved March 2000
Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause, Approved April 2000 Cetrotide; Asta Medica; For the prevention of premature ovulation in women undergoing controlled ovarian stimulation, Approved August 2000 Mirena (levonorgestrel-releasing intrauterine system); Berlex Laboratories; Hormonereleasing system for intrauterine contraception, Approved December 2000 Ovidrel (gonadotropin, chorionic human recombinant); Serono Laboratories; For the induction of final follicular maturation and early luteinization in infertile women, Approved September 2000 Trivagizole 3 (clotrimazole) Vaginal Cream; Taro Pharmaceuticals; For the treatment of vaginal yeast infections, Approved April 2000
Vivelle (estradiol transdermal system); Novartis; For the prevention of postmenopausal osteoporosis, Approved August 2000
Oncology
Mylotarg (gemtuzumab ozogamicin); Wyeth; For the treatment of CD33 positive acute myeloid leukemia (AML), Approved May 2000 Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000 Trisenox (arsenic trioxide); Cell Therapeutics; For the induction of remission and consolidation in patients with acute promyelocytic leukemia (APL), Approved September 2000 Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate cancer, Approved March 2000
Ophthalmology
Betaxon; Alcon; For lowering IOP in patients with chronic open-angle glaucoma or ocular hypertension, Approved February 2000 Quixin (levofloxacin); Santen; For treatment of bacterial conjunctivitis, Approved August 2000 Rescula (unoprostone isopropyl ophthalmic solution) 0.15%; Ciba Vision; For the treatment of open-angle glaucoma or ocular hypertension, Approved August 2000 Visudyne (verteporfin for injection); QLT; For the treatment of wet age-related macular degeneration (wet AMD), Approved April 2000
Otolaryngology
Depakote ER (divalproex sodium); Abbott Laboratories; For the prophylaxis (prevention) of migraine headaches in adults, Approved August 2000 Protonix (pantoprazole sodium) Delayed-Release Tablets; Wyeth; For treatment of erosive esophagitis, Approved February 2000 Tri-Nasal Spray (triamcinolone acetonide spray); Muro Pharmaceutical; For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older, Approved February 2000
Kogenate FS (Antihemophilic Factor Recombinant); Bayer; For the treatment of hemophilia A, Approved June 2000 Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For the treatment of type I and type II diabetes mellitus in adults and pediatrics, Approved April 2000 Lantus (insulin glargine [rDNA origin] injection); Sanofi-aventis; For adults and children w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia, Approved April 2000 Neurontin (gabapentin) oral solution; Parke-Davis; For the treatment of partial seizures in pediatric patients three years of age and older, Approved October 2000 Trileptal (oxcarbazepine) Tablets; Novartis; Approved for use as adjunctive therapy in the treatment of partial seizures in children (monotherapy for adults), Approved January 2000
Concerta; Alza; For the treatment of Attention Deficit Hyperactivity Disorder, Approved August 2000
Biaxin XL (clarithromycin extended-release tablets); Abbott Laboratories; For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis, Approved March 2000 Cefazolin and Dextrose USP; B Braun Medical; Respiratory tract infections, Approved July 2000 Tri-Nasal Spray (triamcinolone acetonide spray); Muro Pharmaceutical; For treatment of nasal symptoms of allergic rhinitis in adults and children age 12 or older, Approved February 2000
Rheumatology
Mobic (meloxicam) Tablets; Boehringer Ingelheim; For relief of the signs and symptoms of osteoarthritis, Approved April 2000
Vivelle (estradiol transdermal system); Novartis; For the prevention of postmenopausal osteoporosis, Approved August 2000

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