Revance Continues to Anticipate FDA Approval of DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines in 2021
NASHVILLE, Tenn., October 12, 2021--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, responds to the public disclosure of its Form 483 pursuant to a Freedom of Information Act (FOIA) request that was directed to the FDA. The Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection remains under FDA review and the company continues to anticipate FDA approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines in 2021.
Revance notes that the issuance of a Form 483 following the conclusion of an on-site inspection is not uncommon. A Form 483 lists observations made by FDA representatives during the inspection of a facility. A Form 483 does not constitute a final agency determination.
Revance provided its response to the Form 483 in July 2021 following a pre-approval inspection and is currently awaiting the FDA’s decision on its BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines. The company remains confident in the quality of its BLA submission and continues to anticipate FDA approval in 2021.
Revance is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the OPUL™ Relational Commerce Platform. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace.
October 13, 2021