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FDA Rejects Eagle Pharma's Vasopressin Application

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  • The FDA has issued a complete response letter (CRL) for Eagle Pharmaceuticals Inc's (NASDAQ: EGRX) abbreviated marketing application seeking vasopressin approval.

  • The company had two conversations with FDA regarding the rejection letter and will have an additional meeting with the agency within 30 days. Eagle Pharma says that it has completed developmental work and continues to do so for its first-to-file polypeptide, where annual brand sales of the product are over $700 million.

  • In its communication with Eagle Pharma, the FDA restated that it has prioritized Eagle's vasopressin application, and it is also flagged as a COVID-19 priority.

  • The company will have to conduct one additional short-duration study that will take place either in mid-February or mid-March. Also, Eagle Pharma expects to have 180 days of exclusivity.

  • Separately, the patent trial case against Endo Par Innovation Company, LLC is now scheduled to begin on July 7. Par's asserted patents claim a formulation with a pH of 3.7-3.9, while Eagle's proposed product specifies a pH outside of that range.

  • Price Action: EGRX shares closed higher by 3.90% at $48.49 on Monday.

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