New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

March 2005

March 1

Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes

March 2

Pfizer and the Sanofi-Aventis Group Seek Approval to Market Exubera in the United States

March 3

Oncologic Drugs Advisory Committee Recommends Against Approval of a Broad Indication For Combidex

March 9

AGI Dermatics 'Breakthrough' Anti-Aging Cream is Singled out by Three Major Media Outlets -- CBS's the Early Show, Prevention Magazine, and Dermatology Times

March 10

FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome

March 11

Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on Baraclude (entecavir), an Investigational Oral Antiviral Agent for Chronic Hepatitis B

March 14

La Jolla Pharmaceutical Announces Outcome of Recent FDA Discussions

March 15

FDA Advisory Panel Recommends Licensure of Sanofi Pasteur's Adacel Vaccine for Combined Protection against Tetanus, Diphtheria and Pertussis GlaxoSmithKline Receives Unanimous Favorable Recommendation by FDA Advisory Committee for Boostrix ID Biomedical to Pursue U.S. Accelerated Approval Process for its Influenza Vaccine - Fluviral

March 24

Advanced Magnetics, Inc. Receives Approvable Letter From FDA For Combidex

March 28

Halozyme Therapeutics Files NDA for Enhanze SC

March 31

Cephalon Files New Drug Application for Nuvigil

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