Posted by Michael Wonder on 24 May 2020
Zealand Pharma announces FDA acceptance of new drug application for the dasiglucagon HypoPal rescue pen for treatment of severe hypoglycemia
22 May 2020 - PDUFA target action date scheduled for 27 March 2021.
Zealand Pharma today announced that the U.S. FDA has accepted for filing the company’s new drug application for the dasiglucagon HypoPal Rescue Pen for the treatment of hypoglycemia in people with diabetes.
Additionally, the FDA has communicated that it is not currently planning on an advisory committee to discuss the application.
