New Drug Applications Archive

New Drug Applications: 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
March 15	GlaxoSmithKline Receives Unanimous Favorable Recommendation by FDA Advisory Committee for Boostrix
March 15	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 30	Biovail Updates Status of NDA for Tramadol ER
March 31	Cephalon Files New Drug Application for Nuvigil

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