ABBV · News · 20260804N
Regulatory Approval Milestones
AbbVie Inc. · 2026-08-04 · Importance 38 · Surprise 60 · In source text
The U.S. Food and Drug Administration accepted Allergan Aesthetics’ supplemental Biologics License Application for BOTOX Cosmetic for review on August 4, 2026. The application seeks approval for the temporary improvement in the appearance of marked to very marked masseter muscle prominence associated with masseter muscle activity in adults. If approved, BOTOX Cosmetic would have five aesthetic indications and would be the first approved neurotoxin for masseter muscle prominence in the United States, supported by two Phase 3 studies.
Key facts
- The U.S. Food and Drug Administration (FDA) has accepted for review Allergan Aesthetics' supplemental Biologics License Application (sBLA) for BOTOX® Cosmetic (onabotulinumtoxinA) for temporary improvement in the appearance of marked to very marked masseter muscle prominence in adults (announcement dated Aug. 4, 2026). source
- 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. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | The U.S. Food and Drug Administration (FDA) has accepted for review Allergan Aesthetics' supplemental Biologics License Application (sBLA)… |