ENDP - Eagle Pharma receives CRL for its marketing application for vasopressin

Eagle Pharmaceuticals ([[EGRX]] +4.7%) expects to submit a full response to the complete response letter (“CRL”) received from the FDA for its Abbreviated New Drug Application (“ANDA”) for vasopressin.The company intends to run an additional short-duration study in mid-February or mid-March that it thinks is required to complete the analysis, and having concluded two meetings with the regulator, the company says it has another meeting within 30 days.Based on similar studies previously run on its vasopressin product, Eagle Pharma expects the results to be satisfactory to win 180 days of exclusivity.In a separate development, the company announced that the trial for the patent dispute against Endo Par is scheduled to begin on July 7.The company remains hopeful of a favorable outcome indicating that the pH range of 3.7-3.9 stated by Endo Par Innovation in its formulation remains outside the range in Eagle’s proposed ANDA product. Endo Par’s parent company is Endo International ([[ENDP]] +6.4%).Last month,

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Eagle Pharma receives CRL for its marketing application for vasopressin