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

Reuters · 01/06/2023 23:01
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 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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