New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

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 Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal 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 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 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 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

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

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

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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