Salix Pharmaceuticals, Ltd. MoviPrep(R) FDA Action Date Established; PDUFA Is August 2, 2006
Published: Jun 21, 2006
RALEIGH, N.C.--(BUSINESS WIRE)--June 21, 2006--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP - News) today announced that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2006 for MoviPrep® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution). As previously announced, the FDA issued an approvable letter for MoviPrep on April 10, 2006 indicating that approval is contingent upon the resolution of certain manufacturing issues. Salix and Norgine, the product's innovator, collaborated to resolve these issues and filed a resubmission to the new drug application for MoviPrep on June 2, 2006. The FDA has acknowledged the receipt of the submission and considers it to be a complete, Class I response to the April 10, 2006 action letter. The FDA has established August 2, 2006 as the user fee goal date.