AbbVie says FDA accepts BOTOX Cosmetic sBLA for masseter muscle prominence indication
ABBV•FDA accepts supplemental BLA for BOTOX Cosmetic
AbbVie says the FDA accepted its supplemental biologics license application seeking to expand BOTOX Cosmetic to treat masseter muscle prominence in adults.
- Approval would add a fifth aesthetic indication in the U.S., positioning BOTOX Cosmetic as the only neurotoxin cleared for the condition.
- The application is backed by two Phase 3 trials showing statistically significant improvement versus placebo (p=0.0046; p=0.0014).
