Allergan Aesthetics Announces U.S. FDA Acceptance of Supplemental Biologics License Application for BOTOX® Cosmetic for Masseter Muscle Prominence

Allergan Aesthetics Announces U.S. FDA Acceptance of Supplemental Biologics License Application for BOTOX® Cosmetic for Masseter Muscle Prominence

* If approved, BOTOX(®) Cosmetic (onabotulinumtoxinA) would be the only neurotoxin with five aesthetic indications and the first and only approved for masseter muscle prominence in the U.S. * Submission is supported by two Phase 3 studies (M21-416 and M21-417), demonstrating statistically significant improvements in masseter muscle prominence and patient satisfaction with treatment IRVINE, Calif., Aug. 4, 2026 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for BOTOX(®) Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence (MMP) associated with masseter muscle activity in adults. If approved, BOTOX(®) Cosmetic would become the first and only neurotoxin indicated for this condition in the U.S. and expand its portfolio to a fifth aesthetic indication.