Posted by Michael Wonder on 06 Jun 2019
Xeris Pharmaceuticals receives notification of PDUFA date extension for Gvoke
6 June 2019 - Xeris Pharmaceuticals announced today that the U.S. FDA has extended the initial Prescription Drug User Fee Act goal date for its review of the Company’s new drug application seeking marketing approval of Gvoke (ready-to-use glucagon injection) by three months.
The new PDUFA goal date is 10 September 2019.
The Company received a notification letter from the FDA on 5 June 2019, which states that the Company’s recent submission in response to an information request from the FDA constitutes a major amendment to the application, and therefore, the FDA is extending the goal date by three months to provide time for a full review of the submission.
