New Drug Applications Archive - October 2005
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October 3, 2005
- Revlimid PDUFA Date Extended Three Months By FDA
- CollaGenex Pharmaceuticals' New Drug Application for Oracea Accepted for Review by FDA; Target PDUFA Date is May 30, 2006
October 4, 2005
October 11, 2005
October 12, 2005
October 17, 2005
October 18, 2005
October 19, 2005
October 21, 2005
- Cephalon Receives Approvable Letter for Sparlon for the Treatment of ADHD in Children and Adolescents
- FDA Accepts Discovery Labs' Complete Response to Approvable Letter for Surfaxin
October 25, 2005
October 26, 2005
October 27, 2005
- Bristol-Myers Squibb Statement on Muraglitazar, an Investigational Oral Treatment For Type 2 Diabetes
- Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee Review
