NPS Pharmaceuticals, Inc. (NPSP) Announces Extension of Action Date for Gattex® NDA to December 30, 2012
8/13/2012 9:23:13 AM
BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has received a communication from the U.S. Food and Drug Administration (FDA) extending the Prescription Drug User Fee Act (PDUFA) action date for its New Drug Application (NDA) for Gattex® (teduglutide) by three months to December 30, 2012. The FDA extended the action date to provide time for a full review of the submission; such extensions are provided for by regulation when information is submitted within three months of a PDUFA action date.
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