FDA expands Botox label for pediatric patients with spasticity

10 July 2020

The US Food and Drug Administration approved a supplemental Biologics License Application (sBLA) that supports expanded use of Botox (onabotulinumtoxinA) for the treatment of spasticity in pediatric patients two years of age and older, including those with lower limb spasticity caused by cerebral palsy, says Allergan.

Since May this year, Allergan became a part of AbbVie (NYSE: ABBV) on completion of the $63 billion acquisition. Therapeutic Botox is major earner, generating sales of $3.79 for the company in 2019.

Based on waiving orphan exclusivity marketing rights

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