FDA sets Aug. 2 PDUFA date for Salix's MoviPrep bowel cleansing agent

By Lisa Kerner

Charlotte, N.C., June 21 - Salix Pharmaceuticals, Ltd. said the Food and Drug Administration has established a Prescription Drug User Fee Act (PDUFA) goal date of Aug, 2, 2006 for its MoviPrep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) bowel cleansing agent.

MoviPrep is under review by the FDA for marketing approval as a bowel cleansing agent prior to colonoscopy, according to a company news release.

The FDA issued an approvable letter for MoviPrep in April. Since then, Salix and Norgine BV, the product's innovator, have resolved manufacturing issues and resubmitted the New Drug Application for MoviPrep on June 2.

Salix said it expects marketing approval and product launch during 2006.

Norgine is a privately owned European specialty pharmaceutical company.

Based in Raleigh, N.C., Salix develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.

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