New Drug Applications Archive

New Drug Applications: January 2009

January 2	New Drug Application Submitted For Acurox Tablets
January 5	UCB Receives Complete Response Letter from U.S. FDA for Use of Cimzia in Rheumatoid Arthritis Patients
January 8	FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults
January 9	FDA Advisory Committee Unanimously Recommends Sabril (vigabatrin) for the Treatment of Two Catastrophic Epilepsies
January 9	GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome
January 9	Merck & Co., Inc. Receives Complete Response Letter from the Food and Drug Administration for Use of Gardasil in Women Ages 27 through 45
January 12	FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn (antithrombin [Recombinant])
January 13	Dyax Announces FDA Advisory Committee to Review DX-88 for Hereditary Angioedema
January 14	FDA Issues Complete Response Letter for Saphris for Acute Treatment of Both Schizophrenia and Bipolar I Disorder
January 15	ISTA Pharmaceuticals' New Drug Application for Bepreve Accepted for Review by U.S. Food and Drug Administration
January 15	Osiris and FDA Reach Agreement on Submission of First Marketing Application for a Stem Cell Product
January 20	FDA Issues Complete Response Letter for Iclaprim
January 20	Pfizer Receives FDA Complete Response Letter for Lasofoxifene
January 20	Review of Takeda's Febuxostat New Drug Application Continues Past PDUFA Date
January 26	ImClone Systems and Bristol-Myers Squibb Update the Status of Non-Small Cell Lung Cancer sBLA Submission for Erbitux
January 26	KV Pharmaceutical's Launch of Gestiva Delayed
January 26	Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes
January 27	Theravance Submits U.S. NDA for Telavancin for the Treatment of Hospital-Acquired Pneumonia
January 28	Alfacell Provides Onconase NDA Submission Update
January 28	Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients
January 30	GlaxoSmithKline and Genmab Submit Arzerra (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer

New Drug Applications Archive

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