AbbVie says FDA accepts BOTOX Cosmetic sBLA for masseter muscle prominence indication

• FDA accepted AbbVie’s supplemental BLA seeking to expand BOTOX Cosmetic to treat masseter muscle prominence in adults.
• Approval would add a fifth aesthetic indication in the US, positioning BOTOX Cosmetic as the only neurotoxin cleared for the condition.
• Application backed by two Phase 3 trials showing statistically significant improvement versus placebo (p=0.0046; p=0.0014).

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AbbVie Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CG18218) on August 04, 2026, and is solely responsible for the information contained therein.