Allergan says FDA accepts sBLAs to expand BOTOX label

Allergan announced that the U.S. FDA has accepted the company’s supplemental biologics license applications to expand the BOTOX label for the treatment of pediatric patients with upper and lower limb spasticity. The pediatric upper limb spasticity indication has been designated a 6-month Priority Review with a Prescription Drug User Fee Act date expected in the second quarter of this year. The pediatric lower limb spasticity indication will undergo a standard 10-month review with a PDUFA date expected in the fourth quarter of 2019.

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