Zogenix Announces FDA Extension of Review Period for FINTEPLA® in Dravet Syndrome
Zogenix, Inc. (ZGNX)
Last zogenix, inc. earnings: 3/2 04:01 pm
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Source: GlobeNewswire
EMERYVILLE, Calif., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome. The new Prescription Drug User Fee Act (PDUFA) target action date has been extended by three months to June 25, 2020. The extension allows the FDA time to review additional data submitted by Zogenix in response to a recent information request from the FDA. The FDA determined that the submission of this information constituted a major amendment to the NDA, resulting in this extension of the PDUFA goal date by three months. “We remain very confident in the data supporting our NDA submission, and look forward to continuing discussions with the FDA during the review process,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix
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