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www.fdanews.com/articles/86001-salix-pharmaceuticals-moviprep-issued-approvable-letter-by-fda

SALIX PHARMACEUTICALS' MOVIPREP ISSUED APPROVABLE LETTER BY FDA

April 12, 2006

Salix Pharmaceuticals has announced that the FDA has issued an approvable letter for prescription MoviPrep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution).

MoviPrep is currently under review by the FDA for marketing approval as a bowel cleansing agent prior to colonoscopy. The comapny licensed exclusive rights to MoviPrep in the U.S. from Norgine B.V., which has filed a patent application for the drug that, if granted, will provide protection until 2023.