Eisai, Imbrium Get FDA OK to File for Insomnia Treatment

Eisai Company, Ltd. (CEO: Haruo Naito, “Eisai”) and Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma, L.P. (President and CEO: Craig Landau, MD), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder. A Prescription Drug User Fee Act (PDUFA) date is set for December 27, 2019.

https://www.biospace.com/article/releases/eisai-and-imbrium-therapeutics-announce-u-s-fda-filing-acceptance-of-new-drug-application-for-lemborexant-for-the-treatment-of-insomnia/