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February 2005
February 1
Advanced Magnetics' Combidex to be Reviewed by FDA Oncologic Drugs Advisory Committee
February 3
FDA Accepts NitroMed's New Drug Application Resubmission for BiDil; Submission Granted a June 23, 2005 PDUFA Date
February 7
Neurocrine Biosciences Announces Resubmission Status of Indiplon
NPS Provides Update on Preos NDA Process and Timing
February 11
FDA Agrees to File Abbott's New Drug Application for Xinlay (Atrasentan) to Treat Metastatic Hormone-Refractory Prostate Cancer
February 14
Discovery Labs Receives Approvable Letter from FDA for Surfaxin for Respiratory Distress Syndrome in Premature Infants
February 24
Vicuron Pharmaceuticals Granted Priority Review of Dalbavancin NDA by FDA in Complicated Skin and Soft Tissue Infections
February 25
FDA Extends PDUFA Action Date for Nebivolol Tablets to May 31, 2005
February 28
Tercica Submits New Drug Application for Increlex as a Treatment for Short Stature Caused by Primary IGF-1 Deficiency
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