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September 2006
September 5
Briefing Documents Posted for FDA Committee Review of Genasense New Drug Application
Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA
September 7
Valera Pharmaceuticals Receives PDUFA Date for Supprelin-LA
September 8
Shire Provides Update on U.S. Marketing Application of Mesavance (mesalamine) With MMX Technology
September 18
GlaxoSmithKline Seeks U.S. Approval for Tykerb (lapatinib ditosylate) for the Treatment of Advanced Breast Cancer
September 20
Alexion Pharmaceuticals Submits Biologics License Application for Soliris (eculizumab)
Access Pharmaceuticals Announces the Filing of an FDA 510(K) Application for MuGard
September 22
DOR BioPharma Files New Drug Application with FDA to Market orBec for GI GVHD
September 28
Discovery Labs Updates Progress On Manufacturing Remediation and Surfaxin FDA Regulatory Matters
September 29
Lilly Announces FDA Requirement of Additional Clinical Trial Before Ruboxistaurin Could Be Approved for Treatment of Diabetic Retinopathy
FDA Issues Approvable Letter for Paliperidone ER for the Treatment of Schizophrenia
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