New Drug Applications Archive
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News Archive for June 2009
June 1, 2009
- Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA
- ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA
June 2, 2009
- ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
- Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency
- GE Healthcare's Application for DaTSCAN (Ioflupane I123 Injection) Accepted by the FDA for Priority Review
June 3, 2009
- Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza (cethromycin)
- Lilly Resubmits Cymbalta Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
- Public Citizen: Antiplatelet Medication Is Unsafe, Should Not Be Approved,Says Scientist Who Helped Develop the Drug
- Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration
June 4, 2009
- Abbott and AstraZeneca Submit New Drug Application to the FDA for Certriad, an Investigational Treatment for Mixed Dyslipidemia
- ViroPharma Receives Complete Response Letter for Cinryze Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema
June 5, 2009
June 8, 2009
June 9, 2009
June 10, 2009
June 11, 2009
- Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo
- Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA
June 12, 2009
June 15, 2009
- BioDelivery Sciences Provides NDA Update for Onsolis
- OSI Pharmaceuticals Announces Acceptance of Tarceva Supplemental New Drug Application for Review by the U.S. Food and Drug Administration
June 16, 2009
- FDA Extends Review of Arzerra (ofatumumab)
- Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws
June 17, 2009
June 24, 2009
June 28, 2009
- Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
- Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
