FDA Accepts BOTOX Cosmetic Application for Masseter Muscle Prominence

The US Food and Drug Administration (FDA) has accepted Allergan Aesthetics’ supplemental Biologics License Application (sBLA) for BOTOX Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence associated with masseter muscle activity in adults.

If approved, the indication would make BOTOX Cosmetic the first neurotoxin approved in the United States for masseter muscle prominence and expand the product to a fifth aesthetic indication, according to Allergan Aesthetics, an AbbVie company.

Phase 3 Studies Support BOTOX Cosmetic sBLA

The submission is supported by 2 phase 3 studies, M21-416 and M21-417, which both met their primary endpoints. BOTOX Cosmetic demonstrated statistically significant improvements in masseter muscle prominence severity compared with placebo (P = .0046 and P = .0014, respectively).

According to the company, the safety profile was consistent with established uses of BOTOX Cosmetic, with no new safety signals identified. The company also reported that twice as many BOTOX Cosmetic-treated patients described themselves as “Very Satisfied” or “Satisfied” with treatment compared with placebo recipients.

“This indication would further broaden the clinical utility of BOTOX Cosmetic, if approved, by providing an important new treatment option,” said coordinating clinical investigator Steve Yoelin, MD, said in a press release.

Source

AbbVie press release. August 6, 2026.