Benzinga | Jun 17, 2021 06:50AM EDT

Eagle Pharmaceuticals Submits Response to Complete Response Letter from FDA for Vasopressin

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that it has responded to the Complete Response Letter ("CRL") for its Abbreviated New Drug Application ("ANDA") for vasopressin received from the U.S. Food and Drug Administration ("FDA") in February 2021.

"We appreciate FDA's insights and based on our post-CRL meeting, believe that we have now responded fully and completely to the CRL. Our ANDA is currently prioritized by FDA and also flagged as a COVID priority. We anticipate having final approval in time to launch the product this year. Vasopressin is an important program for us, with the potential to bring a great deal of value to our shareholders," 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.