February 27, 2020 / 1:31 PM / a month ago

BRIEF-Zogenix Announces FDA Extension Of Review Period For Fintepla In Dravet Syndrome

Feb 27 (Reuters) - Zogenix Inc:

* ZOGENIX ANNOUNCES FDA EXTENSION OF REVIEW PERIOD FOR FINTEPLA® IN DRAVET SYNDROME

* ZOGENIX INC - NEW PDUFA TARGET ACTION DATE HAS BEEN EXTENDED BY THREE MONTHS TO JUNE 25, 2020. FOR FINTEPLA

* ZOGENIX INC - EXTENSION ALLOWS FDA TIME TO REVIEW ADDITIONAL DATA SUBMITTED BY ZOGENIX IN RESPONSE TO A RECENT INFORMATION REQUEST

* ZOGENIX INC - REMAIN VERY CONFIDENT IN DATA SUPPORTING OUR NDA SUBMISSION FOR FINTEPLA FOR TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME

* ZOGENIX INC - FDA DETERMINED THAT SUBMISSION OF INFORMATION CONSTITUTED A MAJOR AMENDMENT TO NDA FOR FINTEPLA Source text for Eikon: Further company coverage:

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