NPS Pharmaceuticals, Inc. (NPSP) Announces FDA Acceptance of New Drug Application for GATTEX® (teduglutide) for the Treatment of Adult Short Bowel Syndrome (SBS)
1/31/2012 6:54:45 AM
BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced the U.S. Food and Drug Administration (FDA) has accepted and filed for review the company’s New Drug Application (NDA) for GATTEX® (teduglutide) for the treatment of adults with short bowel syndrome or SBS. SBS is a rare disorder characterized by inadequate absorption of fluids and nutrients in people who have had a significant portion of their small intestine surgically removed due to disease or injury. GATTEX is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in gastrointestinal regeneration and repair. The acceptance of the GATTEX NDA is the FDA’s determination that the application is sufficiently complete to permit a substantive review.
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