NPS Pharmaceuticals, Inc. (NPSP), a specialty pharmaceutical company, Monday said it has received a communication from the U.S. Food and Drug Administration extending the Prescription Drug User Fee Act action date for its New Drug Application for Gattex or teduglutide by three months to December 30.
The FDA extended the action date to provide time for a full review of the submission. Such extensions are provided for by regulation when information is submitted within three months of a PDUFA action date, the firm noted.
The proposed indication for Gattex is the treatment of adult patients with short bowel syndrome, for which the NDA submission was made in November 2011.
For comments and feedback: editorial@rttnews.com