New Drug Applications Archive

New Drug Applications: March 2007

March 1 Dendreon Announces FDA's Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer
March 7 Nuvo announces further update on discussions with the FDA related to review of Pennsaid
March 12 Cangene Receives an Approvable Letter From the FDA for Human Growth Hormone
March 14 Adams Respiratory Therapeutics' NDA Submission for Prescription Cough Suppressant Accepted by FDA
March 22 Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA
March 23 UCB Provides Update on Cimzia for Crohn's Disease and Rheumatoid Arthritis in the US
March 24 Advancis Pharmaceutical Resubmits New Drug Application for Once-Daily Amoxicillin PULSYS
March 26 Sanofi-aventis Acknowledges FDA Announcement of an Advisory Committee Meeting for rimonabant
March 26 Rimonabant USA: Update
March 27 Dendreon to Hold Post Advisory Committee Conference Call for Provenge
March 27 Roche Submits Application to the FDA for use of Xelox (Xeloda plus oxaliplatin) With or Without Avastin for the Treatment of Advanced Colorectal Cancer
March 29 GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for Cervarix
March 30 Progenics and Wyeth Announce Submission of New Drug Application for the Subcutaneous Formulation of Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients Receiving Palliative Care
March 30 Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer
March 31 GlaxoSmithKline Files Meningococcal Conjugate Vaccine

New Drug Applications Archive

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