PDUFA review date extended to 13 May 2018 for Plenvu bowel cleansing preparation.- Salix/Valeant + Norgine B.V.
Salix Pharmaceuticals, Ltd ,a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., and its partner Norgine B.V. have received notice that the FDA has extended the PDUFA action date for its review of the New Drug Application for PLenvu (NER 1006) by three months to 13 May 2018. The PDUFA action date has been extended to allow the FDA more time to review additional data that was recently provided at its request.
Plenvu was licensed by Salix from Norgine in August 2016 for introduction to the U.S. market. Salix and Norgine will continue to work closely with the FDA to support the review of Plenvu, a next-generation bowel cleansing preparation for colonoscopies.
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