New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

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 Schering-Plough Reports Garenoxacin NDA Accepted for FDA Review 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 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 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" FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006 Santarus Announces FDA Action Date of February 27, 2006 for Zegerid Capsules NDA

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