New Drug Applications Archive

New Drug Applications: November 2008

November 3	Genentech Submits Application to U.S. Food and Drug Administration for Avastin in the Most Aggressive Form of Brain Cancer
November 6	Debiopharm Submits Response to the FDA for Sanvar (Debio 8609) for Esophageal Variceal Bleeding
November 6	Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal
November 6	Sanofi-aventis to Discontinue all Clinical Trials with rimonabant
November 7	BioDelivery Sciences to Meet with FDA to Finalize Proposed REMS for Onsolis
November 10	GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome
November 10	FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Labs' Surfaxin
November 13	AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA
November 14	Watson Announces the NDA for a 6-Month Formulation of Trelstar Accepted for Filing by FDA for the Treatment of Advanced Prostate Cancer
November 14	ISTA Pharmaceuticals Files New Drug Application with U.S. FDA for Bepreve
November 17	Altus Pharmaceuticals Reaffirms Plan to Submit New Drug Applicationfor Trizytek Approval
November 18	FDA Extends Metozolv ODT Review Date
November 20	FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date
November 20	Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections
November 20	Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer
November 20	Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA
November 21	Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome
November 21	FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary Angioedema
November 24	Labopharm's NDA for Novel Trazodone Formulation Accepted for Review by FDA
November 24	FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months
November 24	Genzyme Seeks U.S. Approval for Clolar to Treat Adult AML
November 25	Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout
November 26	FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections

New Drug Applications Archive

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