New Drug Applications: June 2004

June 1	Adolor Submits Second Portion of NDA for Entereg
June 1	SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen
June 1	Miravant's SnET2 New Drug Application Accepted for Filing by FDA with Priority Review Designation
June 2	Allos Therapeutics Receives FDA Approvable Letter for RSR13 (efaproxiral)
June 3	FDA Begins Priority Review of ILEX NDA for Clofarabine in Pediatric Acute Leukemia; Filing Acceptance Indicates Start of Official Review Period
June 15	Discovery Laboratories Announces FDA Acceptance of Surfaxin New Drug Application
June 16	Allos Therapeutics Announces New Trade Names for Efaproxiral in the U.S. and Europe
June 16	Sepracor Announces Resubmission of Estorra NDA to FDA
June 17	Eyetech/Pfizer File New Drug Application for Macugen (pegaptanib sodium injection), the First Investigational Anti-VEGF Therapy for Wet Age-Related Macular Degeneration
June 17	U.S. New Drug Application Approval Expected for Metvix
June 21	NovaDel Pharma files for US FDA approval of Nitroglycerin Lingual Spray, its first product
June 24	Biovail, Depomed Announce Glumetza NDA Accepted by FDA
June 24	Amgen Submits Biologics License Application for FDA Approval of Palifermin
June 24	FDA Extends Action Date for Cymbalta for Continued Analysis of Already-Submitted Data
June 24	Cardiome Receives FDA Approvable Letter on Oxypurinol for Gout
June 28	Adolor Completes Submission of NDA for Entereg
June 28	Elan Files Amendment to New Drug Application for Prialt for Severe Chronic Pain Based on Additional Efficacy and Safety Data
June 29	OSI Pharmaceuticals Announces That Tarceva Has Been Accepted into the FDA's Pilot 1 Program
June 30	Cellegy Submits NDA for Cellegesic to Treat Chronic Anal Fissure Pain
June 30	New Drug Application for Exenatide Submitted to FDA for Type 2 Diabetes
June 30	Alcon Updates Filing Status of Retaane New Drug Application

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New Drug Applications: June 2004

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