New Drugs Approved by Us FDA in 2009-2013

NEW DRUGS APPROVED BY US FDA IN
2009
Cardiology
Vascular Diseases
Adcirca (tadalafil); Eli Lilly; For the treatment of pulmonary arterial hypertension, Approved May
2009
Atryn (antithrombin recombinant lyophilized powder for reconstitution); GTC BioTherapeutics;
For the prevention of peri-operative and peri-partum thromboembolic events, Approved January
2009
Efient (prasugrel); Eli Lilly; for the prevention of thrombotic cardiovascular complications in acute
coronary syndromes, Approved July 2009
Livalo (pitavastatin); Kowa Company; For the treatment of primary hyperlipidemia and mixed
dyslipidemia, Approved August 2009
Multaq (dronedarone); Sanofi-aventis; For the treatment of paroxysmal or persistent atrial
fibrillation or atrial flutter, Approved July 2009
Tyvaso (treprostinil); United Therapeutics; For the treatment of pulmonary arterial hypertension,
Approved July 2009
Dermatology
Stelara (ustekinumab); Janssen Biotech; For the treatment of plaque psoriasis, psoriatic arthritis
and Crohn's disease, Approved September 2009
Vibativ (telavancin); Theravance; For the treatment of complicated skin and skin structure
infections, Approved September 2009
Endocrinology
Cycloset, bromocriptine mesylate; VeroScience; For the treatment of type 2 diabetes mellitus,
Approved May 2009
Onglyza (saxagliptin); Bristol-Myers Squibb; For the treatment of type 2 diabetes mellitus,
Approved July 2009
Family Medicine
2009
Afinitor (everolimus); Novartis; For the treatment of renal cell carcinoma, Approved March 2009
Avastin (bevacizumab); Genentech; For the treatment of renal cell carcinoma, Approved July 2009
Bepreve (bepotastine besilate ophthalmic solution); Ista Pharmaceuticals; For the treatment of
itching associated with allergic conjunctivitis, Approved September 2009
Cambia (diclofenac potassium for oral solution); Kowa Pharmaceuticals; For the treatment of
migraine attacks, Approved June of 2009
Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant;
GlaxoSmithKline; For the prevention of cervical cancer and cervical intraepithelial neoplasia caused
by HPV types 16 and 18, Approved October 2009
Cimzia (certolizumab pegol); UCB; For the treatment of rheumatoid arthritis, Approved May of
2009
Cycloset, bromocriptine mesylate; VeroScience; For the treatment of type 2 diabetes mellitus,
Approved May 2009
Embeda (morphine sulfate and naltrexone hydrochloride); King Pharmaceuticals; For the
treatment of moderate to severe pain, Approved August of 2009
Extavia (Interferon beta-l b); Novartis; For the treatment of relapsing multiple sclerosis, Approved
August of 2009
Intuniv (guanfacine extended-release); Shire Pharmaceuticals; For the treatment of ADHD in
children and adolescents, Approved September 2009
Metozolv ODT (metoclopramide hydrochloride); Salix Pharmaceuticals; For the treatment of
gastroesophageal reflux and diabetic gastroparesis, Approved September of 2009
Onglyza (saxagliptin); Bristol-Myers Squibb; For the treatment of type 2 diabetes mellitus,
Approved July 2009
Onsolis (fentanyl buccal); BioDelivery Sciences; For the management of breakthrough cancer
pain, Approved July 2009
Pennsaid (diclofenac sodium topical solution); Nuvo Research; For the treatment of
osteoarthritis of the knee, Approved November 2009
Sabril (vigabatrin); Lundbeck; For the treatment of infantile spasms and complex partial seizures,
Approved August 2009
Saphris (asenapine); Schering-Plough; For the treatment of schizophrenia and manic or mixed
bipolar 1 episodes, Approved August of 2009
Simponi (golimumab); Centocor Ortho Biotech; For the treatment of rheumatoid arthritis, psoriatic
arthritis and ankylosing spondylitis, Approved April 2009
Approved July 2009
Votrient (pazopanib); GlaxoSmithKline; For the treatment of renal cell carcinoma, Approved
October of 2009
Zipsor (diclofenac potassium); Xanodyne Pharmaceuticals; For the treatment of mild to moderate
acute pain, Approved June 2009
Gastroenterology
Metozolv ODT (metoclopramide hydrochloride); Salix Pharmaceuticals; For the treatment of
gastroesophageal reflux and diabetic gastroparesis, Approved September of 2009
Zenpep (pancrelipase); Eurand; For the treatment of pancreatic insufficiency due to cystic fibrosis
or other conditions, Approved August 2009
Genetic Disease
Berinert (C1 Esterase Inhibitor (Human)); CSL Behring; For the treatment of abdominal or facial
attacks of hereditary angioedema, Approved October 2009
Kalbitor (ecallantide); Dyax; For the treatment of hereditary angioedema, Approved November
2009
Hematology
Arzerra (ofatumumab); GlaxoSmithKline; For the treatment of chronic lymphocytic leukemia,
Approved October 2009
2009
Efient (prasugrel); Eli Lilly; for the prevention of thrombotic cardiovascular complications in acute
coronary syndromes, Approved July 2009
Elitek (rasburicase); sanofi-aventis; For the management of plasma uric acid levels in adults with
malignancies, Approved October 2009
Feraheme (ferumoxytol); AMAG; For the treatment of iron deficiency anemia associated with
chronic kidney disease, Approved June 2009
Folotyn (pralatrexate injection); Allos Therapeutics; For the treatment of peripheral T-cell
lymphoma, Approved September 2009
Istodax (romidepsin); Gloucester Pharmaceuticals; For the treatment of cutaneous T-cell
lymphoma, Approved November 2009
Samsca (tolvaptan); Otsuka; For the treatment of hyponatremia, Approved May of 2009
Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human); Octapharma; For the
treatment of von Willebrand disease, Approved December of 2009
Hepatology (Liver, Pancreatic, Gall Bladder)

October of 2009
Immunology
Besivance (besifloxacin ophthalmic suspension); Bausch & Lomb; For the treatment of bacterial
conjunctivitis, Approved June 2009
Coartem (artemether/lumefantrine); Novartis; For the treatment of malaria infections due to
Plasmodium falciparum, Approved April 2009
Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate); GlaxoSmithKline; For
the prevention of invasive disease caused by Haemophilus influenzae type b., August of 2009
Ilaris (canakinumab); Novartis; For the treatment of Cryopyrin-Associated Periodic Syndromes,
Approved June 2009
Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed); Intercell AG; For the prevention
of disease caused by Japanese encephalitis virus, Approved March 2009
Kalbitor (ecallantide); Dyax; For the treatment of hereditary angioedema, Approved November
2009
Qutenza (capsaicin); NeurogesX; For the treatment of neuropathic pain associated with
postherpetic neuralgia, Approved November 2009
Zirgan (ganciclovir ophthalmic gel); Sirion Therapeutics; For the treatment of acute herpetic
keratitis, Approved September 2009
Infections and Infectious Diseases

Musculoskeletal
2009
Colcrys (colchicine); Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever,
August of 2009
Savella (milnacipran hydrochloride); Forest Laboratories; For the treatment of fibromyalgia,
Approved January 2009
Nephrology
Feraheme (ferumoxytol); AMAG; For the treatment of iron deficiency anemia associated with
chronic kidney disease, Approved June 2009
Gelnique (oxybutynin chloride); Watson Pharmaceuticals; For the treatment of overactive bladder,
October of 2009
Neurology
Cambia (diclofenac potassium for oral solution); Kowa Pharmaceuticals; For the treatment of
migraine attacks, Approved June of 2009
Edluar (zolpidem tartrate); Orexo; For the treatment of insomnia, Approved March 2009
Embeda (morphine sulfate and naltrexone hydrochloride); King Pharmaceuticals; For the
treatment of moderate to severe pain, Approved August of 2009
August of 2009
Qutenza (capsaicin); NeurogesX; For the treatment of neuropathic pain associated with
postherpetic neuralgia, Approved November 2009
Zipsor (diclofenac potassium); Xanodyne Pharmaceuticals; For the treatment of mild to moderate
acute pain, Approved June 2009
Obstetrics/Gynecology (Women’s Health)

Lysteda (tranexamic acid); Xanodyne Pharmaceuticals; For the treatment of heavy menstrual
bleeding, Approved November 2009
Oncology
Arzerra (ofatumumab); GlaxoSmithKline; For the treatment of chronic lymphocytic leukemia,
Avastin (bevacizumab); Genentech; For the treatment of recurrent glioblastoma in adults,
Approved May 2009
Elitek (rasburicase); sanofi-aventis; For the management of plasma uric acid levels in adults with
malignancies, Approved October 2009
Folotyn (pralatrexate injection); Allos Therapeutics; For the treatment of peripheral T-cell
lymphoma, Approved September 2009
Istodax (romidepsin); Gloucester Pharmaceuticals; For the treatment of cutaneous T-cell
lymphoma, Approved November 2009
October of 2009
Ophthalmology
Acuvail (ketorolac tromethamine); Allergan; For the treatment of pain and inflammation following
cataract surgery., Approved July 2009
Besivance (besifloxacin ophthalmic suspension); Bausch & Lomb; For the treatment of bacterial
conjunctivitis, Approved June 2009
Ozurdex (dexamethasone); Allergan; For the treatment of macular edema following branch retinal
vein occlusion or central retinal vein occlusion, Approved June 2009
Zirgan (ganciclovir ophthalmic gel); Sirion Therapeutics; For the treatment of acute herpetic
keratitis, Approved September 2009
Pediatrics/Neonatology
Ilaris (canakinumab); Novartis; For the treatment of Cryopyrin-Associated Periodic Syndromes,
Approved June 2009
Psychiatry/Psychology
Edluar (zolpidem tartrate); Orexo; For the treatment of insomnia, Approved March 2009
Fanapt (iloperidone); Vanda; For the treatment of schizophrenia, Approved May of 2009
Pulmonary/Respiratory Diseases
2009
Approved July 2009
Rare Diseases and Disorders

Rheumatology
2009
Uloric (febuxostat); Takeda; For the treatment of chronic hyperuricemia in patients with gout,
Approved February 2009
Trauma (Emergency, Injury, Surgery)

2009
Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human); Octapharma; For the
treatment of von Willebrand disease, Approved December of 2009
Vaccines

2010
Cardiology/Vascular Diseases
Amturnide (aliskiren + amlodipine + hydrochlorothiazide); Novartis; For the treatment of
uncontrolled hypertension, Approved December 2010
Pradaxa (dabigatran etexilate mesylate); Boehringer Ingelheim; 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
Dermatology
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
Family Medicine
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,
Amturnide (aliskiren + amlodipine + hydrochlorothiazide); Novartis; For the treatment of
uncontrolled hypertension, Approved December 2010
Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October
2010
Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March
2010
Butrans (buprenorphine) Transdermal System; Purdue Pharma; moderate to severe chronic
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
Egrifta (tesamorelin for injection); Theratechnologies; For the reduction of excess abdominal fat in
HIV-infected patients with lipodystrophy, Approved November 2010
Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of
moderate to severe pain, Approved March 2010
Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved
September 2010
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
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
Kapvay (clonidine hydrochloride); Shionogi; For the treatment of attention deficit hyperactivity
disorder, Approved October 2010
Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia),
Approved September 2010
Oleptro (trazodone hydrochloride); Labopharm; For the treatment of major depressive disorder,
Pradaxa (dabigatran etexilate mesylate); Boehringer Ingelheim; For the risk reduction of stroke
and embolism due to atrial fibrillation, Approved October 2010
Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer,
Approved May 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
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
Approved July 2010
Victoza (liraglutide); Novo Nordisk; For the treatment of type 2 diabetes mellitus, Approved January
2010
Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk
for NSAID-associated ulcers, Approved April 2010
Vivitrol (naltrexone for extended-release injectable suspension); Alkermes; For the prevention
of relapse to opioid dependence, Approved October 2010
Zymaxid (gatifloxacin ophthalmic solution); Allergan; For the treatment of bacterial conjunctivitis,
Approved May 2010
Gastroenterology
Pancreaze (pancrelipase); Johnson & Johnson; For the treatment of exocrine pancreatic
insufficiency, Approved April of 2010
Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-
operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010
Genetic Disease
Cayston (aztreonam for inhalation solution); Gilead; For the treatment of cystic fibrosis patients
with Pseudomonas aeruginosa, Approved February 2010
Vpriv (velaglucerase alfa for injection); Shire Pharmaceuticals; For the treatment of type 1
Gaucher disease, Approved March 2010
Hematology
Immunology
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
Zortress (everolimus); Novartis; For the prevention of organ rejection following kidney transplant,
Approved May 2010
Approved May 2010

Approved May 2010
Musculoskeletal
2010
2010
Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved
September 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
Dupuytren’s contracture, Approved February 2010
Nephrology
Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March
2010
Approved May 2010
Xifaxan (rifaximin); Salix Pharmaceuticals; 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
2010
Botox (onabotulinumtoxinA); Allergan; For the treatment of chronic migraine, Approved October
2010
Butrans (buprenorphine) Transdermal System; Purdue Pharma; moderate to severe chronic
Carbaglu (carglumic acid); Recordati; For the treatment of hyperammonemia, Approved March
2010
Exalgo (hydromorphone hydrochloride) extended release; Alza; For the management of
moderate to severe pain, Approved March 2010
Nuedexta (dextromethorphan hydrobromide and quinidine sulfate); Avanir Pharmaceuticals;
For the treatment of pseudobulbar affect, Approved October 2010
Sprix (ketorolac tromethamine); Roxro Pharma; For the treatment of moderate to severe pain,
Approved May 2010
Xifaxan (rifaximin); Salix Pharmaceuticals; For the treatment of hepatic encephalopathy, Approved
March 2010

ella (ulipristal acetate); HRA Pharma; For the emergency prevention of contraception, Approved
August 2010
November 2010
Natazia (estradiol valerate + dienogest); Bayer; For the prevention of contraception, Approved
May 2010
Oncology
November 2010
Approved May 2010
Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone
metastases from solid tumors, Approved November 2010
Ophthalmology
Approved May 2010
Otolaryngology (Ear, Nose, Throat)

Oravig (miconazole); Strativa Pharmaceuticals; oropharyngeal candidiasis, Approved April 2010
Approved July 2010
Pharmacology/Toxicology
Latuda (lurasidone); Sunovion; For the treatment of schizophrenia, Approved October 2010
Oleptro (trazodone hydrochloride); Labopharm; For the treatment of major depressive disorder,
Rheumatology
2010
Sleep

Urology
Approved May 2010
Vaccines
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
2011
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; 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
Dermatology
Firazyr (icatibant); Shire Pharmaceuticals; For the treatment of acute attacks of hereditary
angioedema, Approved August of 2011
Gralise (gabapentin); Abbott Laboratories; 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
Family Medicine
Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain
in opioid-tolerant patients, Approved January 2011
Approved May 2011
Anturol (oxybutynin) Gel; Antares Pharma; For the treatment of overactive bladder, Approved
December 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
Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and
osteoarthritis and prevention of gastric ulcers, Approved April 2011
Edarbi (azilsartan medoxomil); Takeda; For the treatment of hypertension, Approved February
2011
Edarbyclor (azilsartan medoxomil and chlorthalidone); Takeda; For the treatment of
hypertension, Approved December of 2011
Edurant (rilpivirine); Tibotec; For the treatment of HIV-1, Approved May 2011
Exparel (bupivacaine liposome injectable suspension); Pacira Pharmaceuticals; For postsurgical
analgesia, Approved November 2011
Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of neovascular (wet) age-
related macular degeneration, Approved November 2011
Ferriprox (deferiprone); Apotex; For the treatment of transfusional iron overload due to
thalassemia, Approved October 2011
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
Juvisync (sitagliptin and simvastatin); Merck; For the treatment of type II diabetes, Approved
October 2011
Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer
pain, Approved June 2011
Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm
birth, Approved February 2011
Nulojix (belatacept); Bristol-Myers Squibb; For the prevention of organ rejection following kidney
transplant, 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
Potiga (ezogabine); Valeant Pharmaceuticals; For the treatment of partial-onset seizures, Approved
June 2011
May 2011
Tradjenta (linagliptin); Boehringer Ingelheim; For the treatment of type II diabetes, Approved May
2011
Vandetanib (vandetanib); AstraZeneca; For the treatment of thyroid cancer, Approved April 2011
Viibryd (vilazodone hydrochloride); Clinical Data; For the treatment of major depressive disorder,
Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August
of 2011
Xarelto (rivaroxaban); Janssen Pharmaceuticals; For the reduction in the risk of stroke and
systemic embolism resulting from atrial fibrillation, Approved November 2011
March 2011
Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer,
Approved May 2011
Gastroenterology
Approved May 2011
Incivek (telaprevir); Vertex Pharmaceuticals; 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
May 2011
Victrelis (boceprevir); Merck; For the treatment of chronic hepatitis C genotype 1, Approved May
2011
Genetic Disease
June 2011
Hematology
Adcetris (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
Jakafi (ruxolitinib); Incyte; For the treatment of myelofibrosis, Approved November 2011

Approved May 2011
2011
Immunology
Benlysta (belimumab); Human Genome Sciences; For the treatment of systemic lupus
erythematosus, Approved March 2011
February 2011
Approved May 2011
2011

Approved May 2011
February 2011
Approved May 2011
2011
Musculoskeletal
Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis,
Approved April 2011
Nephrology
December 2011
Neurology
February 2011
Approved April 2011
June 2011
Makena (hydroxyprogesterone caproate injection); Hologic; For the prevention of risk of preterm
birth, Approved February 2011
Oncology
Adcetris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and
anaplastic large cell lymphoma, Approved August 2011
Approved May 2011
Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute
lymphoblastic leukemia, Approved November of 2011
May 2011
of 2011
March 2011
Approved May 2011
Ophthalmology

Approved April 2011
of 2011
Rheumatology
Approved April 2011
Sleep

Urology
December 2011
Approved May 2011
Vaccines
Approved April 2011

2012
Eliquis (apixaban); Bristol-Myers Squibb; For the prevention of stroke and systemic embolism
resulting from nonvalvular atrial fibrillation, Approved December 2012
Juxtapid (lomitapide); Aegerion Pharmaceuticals; For the treatment of homozygous familial
hypercholesterolemia, Approved December of 2012
Vascepa (icosapent ethyl); Amarin Pharmaceuticals; For the treatment of hypertriglyceridemia,
Approved July of 2012
Dermatology
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
Belviq (lorcaserin hydrochloride); Arena Pharmaceuticals; For the chronic management of weight
loss, Approved June 2012
Bio-T-Gel (testosterone gel); Teva Pharmaceutical; For the treatment of hypogonadism, Approved
February 2012
Bydureon (exenatide extended-release for injectable suspension); Amylin; For the improvement
of glycemic control in adults with type II diabetes mellitus, Approved January 2012
Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer,
Approved November 2012
Elelyso (taliglucerase alfa); Pfizer; 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 Cushing’s syndrome, Approved February 2012
Lucentis (ranibizumab injection); Genentech; For the treatment of diabetic macular edema,
Qsymia (phentermine + topiramate extended-release); Vivus; For the treatment of chronic weight
management, Approved July 2012
Signifor (pasireotide diaspartate); Novartis; For the treatment of Cushing's disease, Approved
December of 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
Family Medicine
Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the
treatment of non-small cell lung cancer, Approved October 2012
Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with
tuberous sclerosis complex, Approved April 2012
Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative
breast cancer, Approved July 2012
Aubagio (teriflunomide); Sanofi Aventis; For the treatment of multiple sclerosis, Approved
September 2012
Cystaran (cysteamine hydrochloride); Sigma Tau Pharmaceuticals; For the treatment of corneal
cystine crystal accumulation due to cystinosis, Approved October 2012
Dymista (azelastine hydrochloride and fluticasone propionate); Meda Pharmaceuticals Inc; For
the relief of symptoms of seasonal allergic rhinitis, Approved May 2012
2012
Fycompa (perampanel); Eisai; For the treatment of partial-onset seizures with or without
secondarily generalized seizures; tonic-clonic seizures, Approved October 2012
Approved June 2012
Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012
Jentadueto (linagliptin plus metformin hydrochloride); Eli Lilly; For the treatment of type II
diabetes, Approved February 2012
Jetrea (ocriplasmin); Thrombogenics; For the treatment of symptomatic vitreomacular adhesion,
Korlym (mifepristone); Corcept Therapeutics; For the control of hyperglycemia in adults with
endogenous Cushing’s syndrome, Approved February 2012
Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved
July 2012
Linzess (linaclotide); Forest Labs and Ironwood Pharmaceuticals; For the treatment of irritable
bowel syndrome with constipation and chronic idiopathic constipation, Approved August 2012
Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury,
Approved June 2012
Myrbetriq (mirabegron); Astellas Pharma US, Inc; For the treatment of overactive bladder,
Approved June 2012
Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer; For the treatment of heavy
menstrual bleeding, Approved March 2012
Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome,
Approved April 2012
Omontys (peginesatide); Affymax; For the treatment of anemia due to chronic kidney disease,
Approved March 2012
Oxtellar XR (oxcarbazepine extended release); Supernus Pharmaceuticals; For the adjunctive
therapy of partial seizures in adults and in children 6 years to 17 years of age, Approved October
2012
Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer,
Approved June 2012
January 2012
Qnasl (beclomethasone dipropionate) nasal aerosol; Teva Pharmaceutical; For the treatment of
seasonal and perennial allergic rhinitis, Approved March 2012
Quillivant XR (methylphenidate hydrochloride); NextWave Pharmaceuticals; For the treatment of
Attention Deficit Hyperactivity Disorder, Approved September 2012
Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain
inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of
2012
Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012
Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated
patients with metastatic colorectal cancer, Approved September 2012
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate); Gilead; For the
treatment of HIV-1 infection, Approved August 2012
Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer
pain, Approved January of 2012
Surfaxin (lucinactant); Discovery Laboratories; For the treatment of respiratory distress syndrome
in premature infants, Approved March 2012
Tudorza Pressair (aclidinium bromide inhalation powder); Forest Laboratories; For the
maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease,
Approved July 2012
Voraxaze (glucarpidase); BTG International; For the treatment of toxic plasma methotrexate
concentrations in patients with impaired renal function, Approved January 2012
Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis,
Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate
cancer, Approved August 2012
Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer,
Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular
pressure, Approved February 2012
Gastroenterology
Gattex (teduglutide); NPS Pharmaceuticals; For the treatment of short bowel syndrome, Approved
December 2012
Mytesi (crofelemer); Napo Pharmaceuticals; For the treatment of non-infectious diarrhea in adults
with HIV/AIDS, Approved December 2012
Genetic Disease
Juxtapid (lomitapide); Aegerion Pharmaceuticals; For the treatment of homozygous familial
hypercholesterolemia, Approved December of 2012
Kalydeco (ivacaftor); Vertex Pharmaceuticals; For the treatment of cystic fibrosis with the G551D
mutation in the CFTR gene, Approved January of 2012
2012
Hematology
Bosulif (bosutinib); Pfizer; For the treatment of Ph+ chronic myelogenous leukemia, Approved
September 2012
Iclusig (ponatinib); Ariad Pharmaceuticals; For the treatment of chronic myeloid leukemia and
Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012
July 2012
Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; For the treatment of Ph-
acute lymphoblastic leukemia, Approved August 2012
Neutroval (tbo-filgrastim); Teva Pharmaceutical; For the reduction in the duration of severe
chemotherapy-induced neutropenia, Approved August 2012
Approved March 2012
Synribo (omacetaxine mepesuccinate); Teva Pharmaceutical; For the treatment of chronic or
accelerated phase chronic myeloid leukemia, Approved October 2012

Immunology
Flucelvax, Influenza Virus Vaccine; Novartis; For the treatment of influenza virus subtypes A and
type B, Approved November 2012
Approved June 2012
2012
Approved July 2012

Abthrax (raxibacumab); GlaxoSmithKline; For the treatment and prevention of anthrax, Approved
December of 2012
Sirturo (bedaquiline); Janssen Therapeutics; For the treatment of multi-drug resistant tuberculosis,
Approved December 2012
Approved July 2012
Musculoskeletal
Aubagio (teriflunomide); Sanofi Aventis; For the treatment of multiple sclerosis, Approved
September 2012
Approved June 2012
Approved June 2012
Approved April 2012
2012
Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April
2012
Nephrology
Approved June 2012
Approved March 2012
Neurology
Eliquis (apixaban); Bristol-Myers Squibb; For the prevention of stroke and systemic embolism
resulting from nonvalvular atrial fibrillation, Approved December 2012
Approved June 2012
Approved June 2012
Approved April 2012
2012
Nutrition and Weight Loss

Belviq (lorcaserin hydrochloride); Arena Pharmaceuticals; For the chronic management of weight
loss, Approved June 2012
Natazia (estradiol valerate and estradiol valerate/dienogest); Bayer; For the treatment of heavy
menstrual bleeding, Approved March 2012
Approved June 2012
Oncology
Bosulif (bosutinib); Pfizer; For the treatment of Ph+ chronic myelogenous leukemia, Approved
September 2012
2012
Iclusig (ponatinib); Ariad Pharmaceuticals; For the treatment of chronic myeloid leukemia and
Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012
July 2012
Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; For the treatment of Ph-
acute lymphoblastic leukemia, Approved August 2012
Neutroval (tbo-filgrastim); Teva Pharmaceutical; For the reduction in the duration of severe
chemotherapy-induced neutropenia, Approved August 2012
Approved June 2012
January 2012
Synribo (omacetaxine mepesuccinate); Teva Pharmaceutical; For the treatment of chronic or
accelerated phase chronic myeloid leukemia, Approved October 2012
Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April
2012
Ophthalmology
Eylea (aflibercept); Regeneron Pharmaceuticals; For the treatment of macular edema following
retinal vein occlusion, Approved September 2012
Zioptan (tafluprost ophthalmic solution); Merck; For the treatment of elevated intraocular
pressure, Approved February 2012
Orthopedics/Orthopedic Surgery
2012

2012
2012
Sirturo (bedaquiline); Janssen Therapeutics; For the treatment of multi-drug resistant tuberculosis,
Approved December 2012
Approved July 2012
Rheumatology
2012

Approved June 2012
Urology
Bio-T-Gel (testosterone gel); Teva Pharmaceutical; For the treatment of hypogonadism, Approved
February 2012
Approved June 2012
Vaccines
Approved June 2012

2013
Adempas (riociguat); Bayer Healthcare Pharmaceuticals; For the treatment of Chronic
Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, Approved October
2013
Kynamro (mipomersen sodium); Genzyme; For the treatment of homozygous familial
hypercholesterolemia, Approved January 2013
Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May
2013
Nymalize (nimodipine); Arbor Pharmaceuticals; For the reduction of incidence and severity of
ischemic deficits following subarachnoid hemorrhage, Approved May 2013
Opsumit (macitentan); Actelion Pharmaceuticals; For the treatment of pulmonary arterial
hypertension, Approved October 2013
Varithena (polidocanol injectable foam); BTG plc; For the treatment of varicose veins, November
2013
Dermatology
Luzu (luliconazole) Cream 1%; Valeant Pharmaceuticals; For the treatment of interdigital tinea
pedis, tinea cruris, and tinea corporis, November of 2013
Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma
with BRAF V600E or V600K mutations, Approved May of 2013
Mirvaso (brimonidine); Galderma Labs; For the treatment of facial erythema of rosacea, Approved
August 2013
Sitavig (acyclovir) buccal tablets; BioAlliance Pharma; For the treatment of recurrent herpes
labialis in adults, Approved April 2013
Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma
with BRAF V600E mutation, Approved May 2013
Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB
mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013
Varithena (polidocanol injectable foam); BTG plc; For the treatment of varicose veins, November
2013
Devices
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder); GlaxoSmithKline; For the
treatment of chronic obstructive pulmonary disease, Approved May 2013
Endocrinology
Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of
vasomotor symptoms of menopause, Approved July 2013
Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms
associated with menopause and postmenopausal osteoporosis, Approved October 2013
Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus,
Approved April 2013
Nesina (alogliptin); Takeda; For the treatment of type II diabetes mellitus, Approved January 2013
Osphena (ospemifene); Shionogi; For the treatment of dyspareunia and vulvar and vaginal atrophy
due to menopause, Approved March 2013
Family Medicine
Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis,
Approved May 2013
Anoro Ellipta (umeclidinium and vilanterol inhalation powder); GlaxoSmithKline; For the
maintenance treatment of chronic obstructive pulmonary disease, Approved December of 2013
Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets); Duchesnay USA; For
the treatment of nausea and vomiting of pregnancy, Approved April 2013
Flublok (seasonal influenza vaccine); Protein Sciences; For the active immunization against
influenza virus subtypes A and type B, Approved January 2013
Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis,
Approved May 2013
Invokana (canagliflozin); Janssen Pharmaceuticals; For the treatment of type II diabetes mellitus,
Approved April 2013
Liptruzet (ezetimibe and atorvastatin); Merck; For the treatment of hyoerlipidemia, Approved May
2013
Olysio (simeprevir); Janssen Therapeutics; For the treatment of hepatitis C, November of 2013
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the
prevention of conception, Approved April 2013
Sovaldi (sofosbuvir); Gilead Sciences; For the treatment of hepatitis C, December of 2013
Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis,
Approved March 2013
Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013
Xiaflex (collagenase clostridium histolyticum); Auxilium; For the treatment of Peyronie's disease,
Approved December of 2013
Gastroenterology
Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 2013
Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved
February 2013
Uceris (budesonide); Santarus; For the treatment of ulcerative colitis, Approved January 2013
Genetic Disease
Kineret, anakinra; Swedish Orphan Biovitrum; For the treatment of Cryopyrin-Associated Periodic
Syndromes, Approved January 2013
Ravicti (glycerol phenylbutyrate); Hyperion Therapeutics; For the treatment of pediatrics and
adults with urea cycle disorders, Approved February 2013
Tretten (Coagulation Factor XIII A-Subunit [Recombinant]); Novo Nordisk; For the treatment of
congenital factor XIII (FXIII) A-subunit deficiency, Approved December of 2013
Healthy Volunteers
Hematology
Gazyva (obinutuzumab); Genentech; For the treatment of previously untreated chronic lymphocytic
leukemia, Approved October of 2013
Imbruvica (ibrutinib); Pharmacyclics; For the treatment of mantle cell lymphoma, Approved
November of 2013
Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals; For the treatment of iron
deficiency anemia, Approved July 2013
Kcentra (Prothrombin Complex Concentrate); CSL Behring; For the reversal of vitamin K
antagonist therapy-induced coagulation factor deficiency, Approved May 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple
myeloma, Approved February 2013
Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June
2013
Rixubis (Coagulation Factor IX (Recombinant)]; Baxter International; For the routine prophylaxis
and control of hemophilia B, Approved June 2013
Tretten (Coagulation Factor XIII A-Subunit [Recombinant]); Novo Nordisk; For the treatment of
congenital factor XIII (FXIII) A-subunit deficiency, Approved December of 2013

Immunology
Cimzia (certolizumab pegol); UCB; For the treatment of active psoriatic arthritis, Approved
September 2013
Cimzia (certolizumab pegol); UCB; For the treatment of active ankylosing spondylitis , October
2013
Simponi (golimumab); Janssen Biotech; For the treatment of ulcerative colitis, Aproved May 2013
Approved March 2013
Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12
years of age, Approved August 2013
VariZIG, Varicella Zoster Immune Globulin (Human); Cangene; For the post-exposure
prophylaxis of varicella zoster (chickenpox), Approved January 2013

Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated
bacterial pneumonia caused by staph aureus, Approved June 2013
Musculoskeletal
Approved May 2013
September 2013
2013
Approved May 2013
Approved March 2013
Nephrology
Injectafer (ferric carboxymaltose injection); Luitpold Pharmaceuticals; For the treatment of iron
deficiency anemia, Approved July 2013
Procysbi (cysteamine bitartrate); Raptor Pharmaceuticals; For the management of nephropathic
cystinosis, Approved May 2013
Neurology
Aptiom (eslicarbazepine acetate); Sunovion Pharmaceuticals; For the adjunctive treatment of
partial-onset seizures, Approved November 2013
Fetzima (levomilnacipran); Forest Laboratories; For the treatment of major depressive disorder,
Approved July 2013
Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-
clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013
Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules; Zogenix; For the
management of severe pain, Approved October 2013
Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid
dependence, Approved July 2013
Nutrition and Weight Loss

Brisdelle (low-dose paroxetine mesylate); Noven Pharmaceuticals; For the treatment of
vasomotor symptoms of menopause, Approved July 2013
Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets); Duchesnay USA; For
the treatment of nausea and vomiting of pregnancy, Approved April 2013
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic
breast cancer, Approved February 2013
Lo Minastrin, (norethindrone acetate, ethinyl estradiol, ferrous fumarate); Warner Chilcott; For
the prevention of pregnancy, Approved July 2013
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol); Teva Pharmaceutical; For the
prevention of conception, Approved April 2013
Oncology
Gazyva (obinutuzumab); Genentech; For the treatment of previously untreated chronic lymphocytic
leukemia, Approved October of 2013
Gilotrif (afatinib); Boehringer Ingelheim; For the treatment of metastatic non-small cell lung cancer
with EGFR mutations, Approved July 2013
Imbruvica (ibrutinib); Pharmacyclics; For the treatment of mantle cell lymphoma, Approved
November of 2013
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic
breast cancer, Approved February 2013
Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma
with BRAF V600E or V600K mutations, Approved May of 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple
myeloma, Approved February 2013
Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June
2013
Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved
February 2013
Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma
with BRAF V600E mutation, Approved May 2013
Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013
Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of
prostate cancer with bone metastases, Approved May 2013
Orthopedics/Orthopedic Surgery
Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013
Approved May 2013
Approved May 2013
Tivicay (dolutegravir); ViiV HealthCare; For the treatment of HIV-1 in adults and children over 12
years of age, Approved August 2013
Trokendi XR (topiramate); Supernus Pharmaceuticals; For the treatment of partial onset, tonic-
clonic and Lennox-Gastaut Syndrome seizures, Approved August 2013
Podiatry
Brintellix (vortioxetine); Takeda Pharmaceuticals USA; For the treatment of Major Depressive
Disorder, Approved October 2013
Fetzima (levomilnacipran); Forest Laboratories; For the treatment of major depressive disorder,
Approved July 2013
Zubsolv (buprenorphine and naloxone); Orexo AB; For the maintenance treatment of opioid
dependence, Approved July 2013
Adempas (riociguat); Bayer Healthcare Pharmaceuticals; For the treatment of Chronic
Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, Approved October
2013
Anoro Ellipta (umeclidinium and vilanterol inhalation powder); GlaxoSmithKline; For the
maintenance treatment of chronic obstructive pulmonary disease, Approved December of 2013
Opsumit (macitentan); Actelion Pharmaceuticals; For the treatment of pulmonary arterial
hypertension, Approved October 2013
Vibativ (telavancin); Theravance; For the treatment of hospital-acquired and ventilator-associated
bacterial pneumonia caused by staph aureus, Approved June 2013
Rheumatology
Approved May 2013
2013
September 2013
Approved May 2013

Urology
Xiaflex (collagenase clostridium histolyticum); Auxilium; For the treatment of Peyronie's disease,
Approved December of 2013
Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of
prostate cancer with bone metastases, Approved May 2013
Vaccines
This list [PAGES 01 TO 45] has been compiled from the US FDA website by
Dr Prem R Goel
BSc [Bombay],BPharm[Nagpur],MPharm[Bombay]
MS,PhD[USA]MBA[USA]MIQA[UK]
goelngoelassociatesplc
drpremrgoel@gmail.com
+91 7600135939
NOT FOR COMMERCIAL USE

New Drugs Approved by Us FDA in 2009-2013

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NEW DRUGS APPROVED BY US FDA IN

Hepatology (Liver, Pancreatic, Gall Bladder)

Infections and Infectious Diseases

Obstetrics/Gynecology (Women’s Health)

Rare Diseases and Disorders

Trauma (Emergency, Injury, Surgery)