New Drug Applications Archive

New Drug Applications: April 2005

April 1	FDA Requests Further Data on Cilansetron, Solvay's Proposed Treatment for Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)
April 1	Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence
April 1	Sucampo Submits New Drug Application for Lubiprostone, an Investigational Compound for the Treatment of Chronic Idiopathic Constipation
April 8	Revlimid New Drug Application Submitted to FDA for Review
April 11	Merck Submits Biologics License Application to FDA for Rotateq, an Investigational Vaccine for Rotavirus
April 11	FDA Issues Approvable Letter for Ambien CR (Zolpidem Tartrate Extended Release) CIV for the Treatment of Insomnia
April 13	Depomed, Biovail Update Status of Glumetza NDA
April 14	Neurocrine Announces Submission of New Drug Application for Indiplon Capsules
April 18	Cellegy Responds to FDA Inquiries Concerning Cellegesic
April 18	Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis
April 18	FDA Extends PDUFA Date for Megace ES to July 29, 2005
April 20	DOR BioPharma to File NDA for orBec
April 26	Barr's Receives Not Approvable Letter for Bijuva Vaginal Cream
April 28	Santarus Submits New Drug Application for Zegerid Capsules; NDA for First Immediate-Release PPI Capsule Submitted Ahead of Previously Announced Third Quarter Target
April 29	FDA Schedules Advisory Committee Review of BiDil

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