Benzinga | Jun 24, 2021 06:51AM EDT

Eagle Pharmaceuticals Announces FDA Maintains Prioritization of ANDA for Vasopressin

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that the U.S. Food and Drug and Administration ("FDA") has maintained Priority Review for the Company's Abbreviated New Drug Application ("ANDA") for vasopressin. The Company's response to the CRL was submitted on June 15, 2021. The FDA has assigned a GDUFA date of December 15, 2021, and the Company expects a commercial launch prior to year-end.

"Vasopressin is an important program for us, and in light of the Priority Review, as well as its being flagged as a COVID priority, we continue to believe that we can bring this product to market this year. The trial is set to commence on July 7, and we look forward to providing updates in the near future," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Eagle is first to file an ANDA referencing Vasostrict, which had total U.S. sales of $786 million in 2020.