NPS Pharmaceuticals, Inc. (NPSP: Quote) announced that the U.S. Food and Drug Administration, or FDA, has notified the company that its New Drug Application, or NDA, for Gattex (teduglutide) will be discussed at the Gastrointestinal Drugs Advisory Committee meeting scheduled for October 16, 2012. The Prescription Drug User Fee Act date for completion of review by the FDA is December 30, 2012.
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.
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