Posted by Michael Wonder on 17 Jun 2021
Eagle Pharmaceuticals submits response to complete response letter from FDA for vasopressin
17 June 2021 - Eagle Pharmaceuticals today announced that it has responded to the complete response letter for its abbreviated new drug application for vasopressin received from the U.S. FDA in February 2021.
“We appreciate FDA’s insights and based on our post- complete response letter meeting, believe that we have now responded fully and completely to the complete response letter. Our ANDA is currently prioritised 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.
