New Drug Applications Archive

New Drug Applications: June 2009

June 1	Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA
June 1	ARCA biopharma Receives Complete Response Letter From FDA on the Gencaro NDA
June 2	ISTA Pharmaceuticals Announces FDA Advisory Committee to Review Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
June 2	Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency
June 2	GE Healthcare's Application for DaTSCAN (Ioflupane I123 Injection) Accepted by the FDA for Priority Review
June 3	Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza (cethromycin)
June 3	Lilly Resubmits Cymbalta Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
June 3	Public Citizen: Antiplatelet Medication Is Unsafe, Should Not Be Approved,Says Scientist Who Helped Develop the Drug
June 3	Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration
June 4	Abbott and AstraZeneca Submit New Drug Application to the FDA for Certriad, an Investigational Treatment for Mixed Dyslipidemia
June 4	ViroPharma Receives Complete Response Letter for Cinryze Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema
June 5	Somaxon Resubmits New Drug Application for Silenor (Doxepin) for the Treatment of Insomnia
June 8	Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema
June 9	Santarus Announces Schering-Plough Response Submission to FDA for OTC Zegerid
June 10	SkyePharma PLC - Flutiform U.S. Filing Update
June 10	NeurogesX Provides U.S. Regulatory Update for Qutenza
June 11	Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo
June 11	Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA
June 12	FDA Accepts Final Section of NDA Filing for Lucassin
June 15	BioDelivery Sciences Provides NDA Update for Onsolis
June 15	OSI Pharmaceuticals Announces Acceptance of Tarceva Supplemental New Drug Application for Review by the U.S. Food and Drug Administration
June 16	FDA Extends Review of Arzerra (ofatumumab)
June 16	Bioalliance Pharma Submits Loramyc NDA to US FDA And Announces a General Shareholders' Meeting to Amend Its By-Laws
June 17	FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout
June 24	Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
June 28	Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
June 28	Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
June 30	Pozen Submits New Drug Application For Vimovo (PN 400)
June 30	Cephalon Submits Nuvigil Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

New Drug Applications Archive

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