New Drug Applications Archive - November 2008
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November 3, 2008
November 6, 2008
- Debiopharm Submits Response to the FDA for Sanvar (Debio 8609) for Esophageal Variceal Bleeding
- Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal
- Sanofi-aventis to Discontinue all Clinical Trials with rimonabant
November 7, 2008
November 10, 2008
- GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome
- FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin
November 13, 2008
November 14, 2008
- Watson Announces the NDA for a 6-Month Formulation of Trelstar Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer
- ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve
November 17, 2008
November 18, 2008
November 20, 2008
- FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date
- Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
- Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer
- Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA
November 21, 2008
- Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome
- FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema
November 24, 2008
- Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA
- FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months
- Genzyme Seeks U.S. Approval for Clolar to Treat Adult AML
