New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

April 2005

April 1

FDA Requests Further Data on Cilansetron, Solvay's Proposed Treatment for Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D) Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence 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 13

Depomed, Biovail Update Status of Glumetza NDA

April 14

Neurocrine Announces Submission of New Drug Application for Indiplon Capsules

April 18

Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis FDA Extends PDUFA Date for Megace ES to July 29, 2005 Cellegy Responds to FDA Inquiries Concerning Cellegesic

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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