Trials & Filings

FDA Approves Expanded Use for BOTOX

For the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.

By: Contract Pharma

Contract Pharma Staff

Allergan and AbbVie received approval from the U.S. FDA for its supplemental Biologics License Application (sBLA) for expanded use of BOTOX for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy. This label expansion is based on Allergan and another manufacturer selectively waiving orphan exclusivity marketing rights each company held for the use of their respective neurotoxins in the treatment of pe...

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