New Drug Applications Archive

New Drug Applications: March 2006

March 1 Genasense New Drug Application Accepted for Review by FDA
March 1 BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine; Company Has Requested a Meeting with the FDA to Gain Clarity on Notification
March 1 Neupro Receives Approvable Letter from FDA for Early Parkinson's Disease in USA
March 2 UCB Submits Biologics License Application to FDA for New Treatment in Crohn's Disease
March 6 Tibotec Announces FDA Acceptance for Review of NDA for TMC114
March 7 Altana Submitted New Drug Applications For Ciclesonide Nasal Spray in the U.S. and Canada; Major Milestone in Broadening the Ciclesonide Product Platform
March 7 FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Dasatinib
March 10 NPS Receives Approvable Letter for Preos NDA
March 10 FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response
March 17 Barr Confirms that Additional Clinical Data Is Not Required for Approval of Duramed's Seasonique Extended-Cycle Oral Contraceptive
March 22 Novelos Therapeutics Files IND for Novel Hepatitis C Drug; IND Represents Company's Second Clinical Stage Compound
March 23 FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents
March 23 GlaxoSmithKline Submits Biologics License Application for FDA Approval of FluLaval
March 24 Encysive Pharmaceuticals Receives Approvable Letter From FDA for Thelin
March 28 Inspire Announces Outcome of FDA Meeting on Dry Eye Program
March 28 Inspire Announces Outcome of FDA Meeting on Dry Eye Program
March 29 NPS Updates Status of Preos NDA
March 29 Axcan submits FDA amendment to its new drug application for Helizide
March 30 New drug application for Galvus, an innovative oral therapy for people with type 2 diabetes, accepted for review by FDA
March 30 Amgen and Abgenix Complete Biologics License Application for FDA Approval of Panitumumab
March 31 New Drug Application Submitted For RSD1235
March 31 Prestwick Pharmaceuticals Receives FDA Approvable Letter for Xenazine (Tetrabenazine) for Treatment of Chorea Associated with Huntington's Disease

New Drug Applications Archive

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