Posted by Michael Wonder on 03 Feb 2021
Eagle Pharmaceuticals receives additional FDA questions regarding vasopressin; court date set for 7 July 2021 in vasopressin trial
2 February 2021 - Company expects it will have 180 days of exclusivity.
Eagle Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter for its abbreviated new drug application for vasopressin.
Eagle has now had two conversations with FDA regarding the complete response letter and will have an additional meeting with FDA within 30 days. Importantly, Eagle has completed an extensive amount of developmental work and continues to do so for its first to file polypeptide, where brand sales of the product are over $700 million annually.
In its communication with the Company, FDA restated that it has prioritised Eagle’s application, and it is also flagged as a COVID priority.
