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FDA Accepts Review of AbbVie’s Supplemental Botox Cosmetic for Masseter Use

AbbVie logoAbbVie
Sig3.05Sen+3.60Env0.00Soc+1.35Gov+0.70

AbbVie’s supplemental Biologics License Application for Botox Cosmetic to treat masseter muscle prominence was accepted for FDA review on August 4. Two Phase 3 studies showed statistically significant improvement versus placebo, with no new safety concerns. If approved, it would be the first and only US neurotoxin for that use and the fifth aesthetic indication, supporting strong brand momentum.

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