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Thursday, September 26, 2019

Zogenix refiles Fintepla application in U.S.

Zogenix (NASDAQ:ZGNX) has resubmitted its marketing application to the FDA seeking approval of FINTEPLA (fenfluramine) for the treatment of a severe form of childhood-onset epilepsy called Dravet syndrome.
In April it received a Refusal to File letter from the agency meaning that the application was not complete enough to review.

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