Latest New Drug Approvals

Eovist (gadoxetate disodium)

Date of Approval: July 3, 2008
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Diagnostic

Eovist (gadoxetate disodium) is a gadolinium-based contrast agent for intravenous

use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and
characterize lesions in adults with known or suspected focal liver disease.* FDA
Approves Eovist to Detect and Characterize Focal Liver Lesions - July 8, 2008

Evolence (dermal filler)

Date of Approval: June 30, 2008
Company: OrthoNeutrogena
Treatment for: Facial Wrinkles
Evolence is a collagen-based structural dermal filler for the correction of
moderate to deep facial wrinkles and folds, such as nasolabial folds.
* FDA Approves Evolence, a New Generation Collagen-Based Facial Filler - June
30, 2008

Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and
Inactivated Poliovirus Vaccine)
Date of Approval: June 24, 2008
Company: GlaxoSmithKline
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Poliomyelitis
Prophylaxis, Pertussis Prophylaxis
Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and
Inactivated Poliovirus Vaccine] is a combination vaccine for protection against
diphtheria, tetanus, pertussis and polio diseases in children.
* FDA Approves Kinrix - New Combination Vaccine for Children - June 25, 2008

Durezol (difluprednate) Ophthalmic Emulsion

Date of Approval: June 23, 2008
Company: Sirion Therapeutics, Inc.
Treatment for: Postoperative Ocular Inflammation
Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment
of postoperative ocular inflammation and pain.
* Sirion Therapeutics Announces FDA Approval of Durezol for Treatment of
Postoperative Ocular Inflammation and Pain - June 24, 2008
* Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA
for Durezol in the Treatment of Postoperative Ocular Inflammation - February 27,
2008

PrandiMet (repaglinide and metformin) Tablets

Date of Approval: June 23, 2008
Company: Sciele Pharma, Inc. and Novo Nordisk Inc.
Treatment for: Diabetes Mellitus Type II
PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-
acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer,
metformin, indicated for the treatment of type 2 diabetes.
* FDA Approves PrandiMet, a Replaglinide and Metformin Fixed-Dose Combination
Tablet for Treatment of Type 2 Diabetes - June 24, 2008
Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed,
Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)
Vaccine)
Date of Approval: June 20, 2008
Company: Sanofi pasteur
Treatment for: Pertussis Prophylaxis, Tetanus Prophylaxis, Diphtheria Prophylaxis,
Poliomyelitis Prophylaxis, Haemophilus influenzae Prophylaxis
Pentacel is a combination vaccine indicated for active immunization against
diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to
Haemophilus influenzae type b in children 6 weeks through 4 years of age.
* U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine,
Pentacel - June 23, 2008
* FDA Advisory Committee Recommends Licensure of New Pediatric Combination
Vaccine - January 25, 2007
* FDA Accepts for Filing a License Application for New Pediatric Combination
Vaccine, Pentacel - September 26, 2005

This is only a few examples