FDA Accepts NPS Pharmaceuticals’ Supplemental New Drug Application for Gattex

The U.S. Food and Drug Administration has accepted NPS Pharmaceuticals’ supplemental new drug application for Gattex, a drug to treat adults with short bowel syndrome.

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NPS Pharmaceutical conducted a two-year phase III STEPS 2 extension study and would like to include the new data on the Gattex label. The FDA’s decision on label expansion should come by June 2014.

The pharmaceutical company presented this data at the most recent American College of Gastroenterology annual meeting.

Gattex has been available in the U.S. since February and was cleared in the European Union in 2012.

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