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AbbVie Unit Says FDA Accepts BOTOX Cosmetic Application for Masseter Muscle Prominence

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AbbVie's (ABBV) Allergan Aesthetics unit said Tuesday that the US Food and Drug Administration has accepted for review its supplemental biologics license application for BOTOX Cosmetic, or onabotulinumtoxinA for masseter muscle prominence.

The application seeks approval for the temporary improvement of marked to very marked masseter muscle prominence related to masseter muscle activity in adults, the company said, adding that if approved, BOTOX Cosmetic would be the first and only neurotoxin in the US approved for this condition.

The application was backed by two phase 3 trials that met their primary endpoints and showed "statistically significant" improvements in masseter muscle prominence compared with placebo, the company said.

Price: $244.35, Change: $-0.75, Percent Change: -0.31%

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