Eagle Pharma Receives CRL From FDA On Vasopressin

(RTTNews) - Eagle Pharmaceuticals Inc. (EGRX) said Tuesday that it has received a complete response letter or CRL from the U.S. Food and Drug Administration for its Abbreviated New Drug Application or "ANDA" for vasopressin.

Eagle has now had two conversations with FDA regarding the CRL and will have an additional meeting with FDA within 30 days.

Eagle said it 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 prioritized Eagle's ANDA, and it is also flagged as a COVID priority.

Eagle believes it could fully respond to the questions raised. There is one additional short duration study that will need to be completed and analyzed. The study will be run either in mid-February or mid-March. Based on similar studies previously run on the Company's vasopressin product, Eagle expects the results will be satisfactory. In addition, the company expects it will have 180 days of exclusivity.

In other vasopressin news, the patent case against Endo Par Innovation Company is now scheduled to begin on July 7, 2021. Eagle remains confident about this litigation. Par's asserted patents claim a formulation with a pH of 3.7-3.9. Eagle's proposed ANDA product specifies a pH outside of that range.