Research & Development
Revance confident of FDA approval of DaxibotulinumtoxinA for Injection
13 October 2021 -

Biotechnology company Revance Therapeutics Inc (Nasdaq:RVNC) revealed on Tuesday that the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection remains under US FDA review for the treatment of glabellar lines in 2021.

Revance said that DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.

In conjunction, the company provided its response to the Form 483 and is confident in the quality of its DaxibotulinumtoxinA for Injection BLA submission and continues to anticipate FDA approval in 2021. A Form 483 does not constitute a final agency determination.

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