NPS Pharma: FDA Accepts For Review SNDA For Gattex - Quick Facts

(RTTNews) - NPS Pharmaceuticals, Inc. (NPSP), a biopharmaceutical company, announced that the U.S. FDA has accepted for review its Supplemental New Drug Application (sNDA) for Gattex for injection.

In the U.S., Gattex is indicated for the treatment of adult patients with Short Bowel Syndrome, or 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.

The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of June 28, 2014.