New Drug Applications: February 2006

February 2	Biologics License Application for Gardasil, Merck's Investigational Cervical Cancer Vaccine, Is On Track
February 7	Gardasil, Merck's Investigational Cervical Cancer Vaccine, to Receive Priority Review from the U.S. Food and Drug Administration
February 13	Neurochem Submits NDA for Fibrillex
February 13	Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review
February 13	Sepracor's Arformoterol NDA Filed by FDA; Drug Candidate for Chronic Obstructive Pulmonary Disease Moves Into Formal Review
February 14	GlaxoSmithKline's Topical Antibacterial Retapamulin Accepted for Review by The U.S. Food and Drug Administration
February 15	Merck Announces FDA Acceptance of New Drug Application for Januvia, the Company's Investigational Medicine for Type 2 Diabetes
February 16	BioSante Pharmaceuticals Announces Bio-E-Gel NDA Submission
February 17	Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation
February 17	Alkermes Announces Submission of Complete Response to FDA for Vivitrol New Drug Application
February 22	Biovest International Submits Amendment Request to FDA for Use of Molecular Remission Data in the Ongoing Pivotal Phase 3 Study to Support Accelerated, Conditional Approval of BiovaxID, a Personalized Anti-Cancer Vaccine for Non-Hodgkin's Lymphoma
February 23	Replidyne and Forest Laboratories Announce FDA Acceptance for Review of New Drug Application for Oral Antibiotic Faropenem Medoxomil
February 23	Replidyne and Forest Announce FDA Acceptance for Review of NDA
February 24	Novartis receives approvable letter" from the FDA for zoledronic acid 5 mg in the treatment of Paget's disease of the bone"
February 24	FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006
February 24	Santarus Announces FDA Action Date of February 27, 2006 for Zegerid Capsules NDA

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New Drug Applications: February 2006

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