New Drug Applications Archive - June 2009
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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
- Paclitaxel Poliglumex (OPAXIO Added to Cisplatin and Radiation Produces 45% Pathologic Complete Remissions in Patients With Esophageal Cancer
- Somaxon Resubmits New Drug Application for Silenor (Doxepin) for the Treatment of Insomnia
June 8, 2009
June 9, 2009
June 10, 2009
- SkyePharma Inc. Says FDA May Need More Flutiform Data
- NeurogesX Provides U.S. Regulatory Update for Qutenza
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
