Brief: Revance Announces U.S. FDA Acceptance Of Supplemental Biologics License Application (Sbla) For Daxxify® (Daxibotulinumtoxina-Lanm) For Injection For The Treatment Of Cervical Dystonia

Revance Therapeutics

06/01/2023 23:01

Jan 6 (Reuters) - Revance Therapeutics Inc  RVNC.O :
    * REVANCE ANNOUNCES U.S. FDA ACCEPTANCE OF SUPPLEMENTAL
BIOLOGICS
LICENSE APPLICATION (SBLA) FOR DAXXIFY®
(DAXIBOTULINUMTOXINA-LANM) FOR INJECTION FOR THE TREATMENT OF
CERVICAL DYSTONIA
    * REVANCE THERAPEUTICS INC - PRESCRIPTION DRUG USER FEE ACT
(PDUFA) DATE OF AUGUST 19, 2023
    * REVANCE THERAPEUTICS INC - DAXXIFY WAS SHOWN TO BE
EFFECTIVE,
GENERALLY SAFE AND WELL TOLERATED ACROSS BOTH DOSE GROUPS, 125U
AND 250U

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