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October 2006
October 2
VIVUS Submits New Drug Application With U.S. Food and Drug Administration for EvaMist
Alfacell Completes Non-Clinical Section of Rolling NDA for Lead Anticancer Drug Onconase
October 5
Inspire Continues Discussions with FDA on Dry Eye Program
October 6
FDA Issues Approvable Letter for NRP104 (lisdexamfetamine dimesylate) for the Treatment of ADHD
Wyeth Submits NDA and MAA for Torisel for the Treatment of Advanced Renal Cell Carcinoma
October 12
Solvay Pharmaceuticals and Wyeth Announce Submission of New Drug Application for Bifeprunox to Treat Schizophrenia
MGI Pharma Receives Approvable Letter for Saforis (Glutamine) Powder in UpTec for Oral Suspension
October 16
Neurochem submits a complete response to FDA approvable letter for Kiacta
October 23
U.S. Food and Drug Administration Issues Non-Approvable Letter for Faropenem
Adeza Receives FDA Approvable Letter for Gestiva
October 26
IDM Pharma Submits New Drug Application to the FDA for Junovan (mifamurtide) in the Treatment of Osteosarcoma
October 30
FDA Extends Review Period for Genasense New Drug Application in Chronic Lymphocytic Leukemia
October 31
Avanir Receives FDA Approvable Letter for Zenvia for the Treatment of Involuntary Emotional Expression Disorder
New Drug Applications Archive
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