New Drug Applications Archive - January 2009
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January 2, 2009
January 5, 2009
January 8, 2009
January 9, 2009
- 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, 2009
January 13, 2009
January 14, 2009
January 15, 2009
- 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, 2009
- 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, 2009
- 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, 2009
January 28, 2009
- Alfacell Provides Onconase NDA Submission Update - Jan 28, 2009
- Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients
