Allergan Aesthetics Announces U.S. FDA Acceptance of Supplemental Biologics License Application for BOTOX® Cosmetic for Masseter Muscle Prominence
· cision pr newswire
AI Briefing
- • Allergan Aesthetics submits supplemental BLA for BOTOX Cosmetic for masseter muscle prominence treatment.
- • If approved, BOTOX Cosmetic would have five aesthetic indications and first approval for masseter muscle prominence.
- • Submission is supported by two Phase 3 studies demonstrating statistically significant results.
Context
Allergan Aesthetics has announced that the U.S. FDA has accepted a supplemental biologics license application for BOTOX Cosmetic. The application is for the treatment of masseter muscle prominence. If approved, BOTOX Cosmetic would have five aesthetic indications.
The submission is supported by two Phase 3 studies, M21-416 and M21-417, which demonstrated statistically significant results. Approval would make BOTOX Cosmetic the first and only neurotoxin approved for masseter muscle prominence in the U.S.
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