NPS Pharmaceuticals, Inc. Announces FDA Acceptance of Supplemental New Drug Application For Gattex® (Teduglutide [rDNA Origin]) For Injection
Published: Nov 13, 2013
BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Supplemental New Drug Application (sNDA) for Gattex® (teduglutide [rDNA origin]) for injection. In the U.S., Gattex is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The company is seeking additions to the product label for long-term data from STEPS 2, a two-year open-label extension study in which 88 adult patients with SBS dependent on parenteral support received Gattex 0.05 mg/kg/day.
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