A six-month review period has been assigned for the sBLA and the Prescription Drug User Fee Act (PDUFA) date is expected to be in the first quarter of next year.
The resubmission of sBLA provides additional data from a double-blind, placebo controlled trial involving 468 patients with lower limb spasticity.
Allergan Botox chief scientific officer and Global Development senior vice-president Mitchell Brin said: "We have continued to work closely with the FDA to prepare our resubmission and we are confident that the additional information requested is addressed.
"This FDA acceptance represents our ongoing commitment to research and development, and efforts to bring to market the first-approved focal therapy for lower limb spasticity for physicians and patients."
This April, the FDA approved an expansion of the Botox (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity.
The company noted that the expanded label includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb; and adductor pollicis, a muscle in the hand that functions to adduct the thumb; increasing the maximum dose from 360 to 400 units to treat upper limb spasticity.
The FDA also approved an increase to the maximum Botox cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.