FDA extends PDUFA action date for NPS Gattex NDA

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.

Gattex is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in normal intestinal function and fluid and nutrient absorption. The proposed indication for Gattex is the treatment of adult patients with short bowel syndrome. The company completed its NDA submission for Gattex in November 2011.

Source:

 NPS Pharmaceuticals

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