Allergan Aesthetics Reports the US FDA’s sBLA Acceptance of Botox Cosmetic for Masseter Muscle Prominence
Shots:
- The US FDA has accepted sBLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked MMP associated with masseter muscle activity in adults
- sBLA was supported by 2 P-III (M21-416 and M21-417) studies, both of which met their 1EPs & showed improvements in the severity of MMP vs PBO, along with a favorable safety profile
- Additionally, patient satisfaction was also higher with Botox Cosmetic, with twice as many patients reporting they were “Very Satisfied” or “Satisfied” compared with PBO
Ref: PRnewswire | Image: Allergan Aesthetics | Press Release
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