New Drug Applications Archive

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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 GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome 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 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 Pfizer Receives FDA Complete Response Letter for Lasofoxifene 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 KV Pharmaceutical's Launch of Gestiva Delayed 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 - Jan 28, 2009 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

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