Brief: Zevra Therapeutics Says US FDA Has Extended Review Period For Arimoclomol NDA

Zevra Therapeutics

04/03/2024 12:45

March 4 (Reuters) - Zevra Therapeutics Inc  ZVRA.O :
    * ZEVRA THERAPEUTICS PROVIDES FDA UPDATE ON THE PDUFA ACTION
DATE
FOR ARIMOCLOMOL AS A TREATMENT FOR NIEMANN-PICK DISEASE TYPE C
    * ZEVRA THERAPEUTICS INC: NEW PRESCRIPTION DRUG USER FEE ACT
(PDUFA) ACTION DATE SET BY FDA IS SEPTEMBER 21, 2024
    * ZEVRA THERAPEUTICS INC: FDA HAS EXTENDED REVIEW PERIOD FOR
NDA
FOR ARIMOCLOMOL
    * ZEVRA THERAPEUTICS INC: FDA HAS RE-AFFIRMED ITS INTENT TO
PRESENT RESUBMISSION FOR DISCUSSION AT AN ADVISORY COMMITTEE
MEETING TO BE SCHEDULED
    * ZEVRA THERAPEUTICS INC: FDA HAS DETERMINED THAT ADDITIONAL
INFORMATION CONSTITUTES A MAJOR AMENDMENT TO NDA

Source text for Eikon:  ID:nGNX5kjD3x 
Further company coverage:  ZVRA.O 

 ((Reuters.Briefs@thomsonreuters.com;))