Posted by Michael Wonder on 28 Jun 2021
Eagle Pharmaceuticals announces FDA maintains prioritisation of ANDA for vasopressin
24 June 2021 - Assigned GDUFA date of 15 December 2021, and expects commercial launch prior to year-end.
Eagle Pharmaceuticals today announced that the U.S. FDA has maintained priority review for the Company’s abbreviated new drug application for vasopressin.
The Company’s response to the complete response letter was submitted on 15 June 2021.
