The FDA has accepted AbbVie's supplemental Biologics License Application (sBLA) for BOTOX in masseter hypertrophy—the cosmetic indication for jawline prominence reduction. The acceptance signals the agency's preliminary view that the application is complete and substantively reviewable, clearing a key regulatory hurdle.
Masseter BOTOX represents a meaningful expansion of the toxin's cosmetic label and a direct competitive response to Revance's Daxxify, which already carries the indication. The masseter market—driven by younger demographics and aesthetic demand for facial contouring—has grown faster than traditional glabellar and lateral canthal uses, and label approval will likely accelerate adoption among practices seeking new revenue streams.