Posted by Michael Wonder on 29 Oct 2018
Xeris Pharmaceuticals announces FDA acceptance for review of NDA for its ready-to-use glucagon rescue pen
23 October 2018 - If approved, the Xeris glucagon rescue pen would be the first ready-to-use, room-temperature stable liquid glucagon in an auto-injector to treat severe hypoglycaemia.
Xeris Pharmaceuticals announced today that its new drug application for its ready-to-use, room-temperature stable liquid glucagon rescue pen for the treatment of severe hypoglycaemia in people with diabetes has been accepted for review by the U.S. FDA.
The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of the glucagon rescue pen application of 10 June 2019.
