New Drug Applications Archive - June 2004
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June 1, 2004
- SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen
- Adolor Submits Second Portion of NDA for Entereg
- Miravant's SnET2 New Drug Application Accepted for Filing by FDA with Priority Review Designation
June 2, 2004
June 3, 2004
June 15, 2004
June 16, 2004
- Allos Therapeutics Announces New Trade Names for Efaproxiral in the U.S. and Europe
- Sepracor Announces Resubmission of Estorra NDA to FDA
June 17, 2004
- Eyetech/Pfizer File New Drug Application for Macugen (pegaptanib sodium injection), the First Investigational Anti-VEGF Therapy for Wet Age-Related Macular Degeneration
- U.S. New Drug Application Approval Expected for Metvix
June 21, 2004
June 24, 2004
- Cardiome Receives FDA Approvable Letter on Oxypurinol for Gout
- FDA Extends Action Date for Cymbalta for Continued Analysis of Already-Submitted Data
- Biovail, Depomed Announce Glumetza NDA Accepted by FDA
- Amgen Submits Biologics License Application for FDA Approval of Palifermin
June 28, 2004
- Elan Files Amendment to New Drug Application for Prialt for Severe Chronic Pain Based on Additional Efficacy and Safety Data
- Adolor Completes Submission of NDA for Entereg
