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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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