New Drug Applications Archive - March 2006
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March 1, 2006
- BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine; Company Has Requested a Meeting with the FDA to Gain Clarity on Notification
- Genasense New Drug Application Accepted for Review by FDA
- Neupro Receives Approvable Letter from FDA for Early Parkinson's Disease in USA
March 2, 2006
March 6, 2006
March 7, 2006
- FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Dasatinib
- Altana Submitted New Drug Applications For Ciclesonide Nasal Spray in the U.S. and Canada; Major Milestone in Broadening the Ciclesonide Product Platform
March 10, 2006
- NPS Receives Approvable Letter for Preos NDA
- FDA Declares Daytrana NDA Resubmission to Be Complete Class I Response
March 17, 2006
March 22, 2006
March 23, 2006
- FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents
- GlaxoSmithKline Submits Biologics License Application for FDA Approval of FluLaval
March 24, 2006
March 28, 2006
- Inspire Announces Outcome of FDA Meeting on Dry Eye Program
- Inspire Announces Outcome of FDA Meeting on Dry Eye Program
March 29, 2006
- NPS Updates Status of Preos NDA
- Axcan submits FDA amendment to its new drug application for Helizide
March 30, 2006
- Amgen and Abgenix Complete Biologics License Application for FDA Approval of Panitumumab
- New drug application for Galvus, an innovative oral therapy for people with type 2 diabetes, accepted for review by FDA
