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# Allergan sBLA for Botox Accepted for Review
- URL: https://www.fdaweb.com/allergan-sbla-for-botox-accepted-for-review/
- Published: 2026-08-04T12:00:00.000Z
- Updated: 2026-09-14T13:44:28.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161571

FDA has accepted for review an Allergan Aesthetics supplemental BLA 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.

“MMP can contribute to the appearance of a wider or more square lower face,” the company says. “This submission addresses a growing patient interest in non-surgical facial contouring options, offering a clinically studied approach to achieving improved jawline definition and shape, as well as a more slimming jawline overall. If approved, this indication would provide both patients and aesthetic specialists with a differentiated, science-backed treatment option.”

The submission is based on data from two Phase 3 clinical studies (M21-416 and M21-417), both of which met their primary endpoints and demonstrated statistically significant improvements in the severity of masseter muscle prominence compared with placebo, according to the company. The safety profile was also consistent with established uses, with no new safety signals identified, it adds.