Topiramate oral solution is accepted for filing by the FDA for seizures and for migraine prevention.

Eton Pharmaceuticals, Inc. announced the FDA has accepted for filing the company’s new drug application (NDA) for topiramate oral solution. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of August 6, 2021. The application was submitted for three indications, including: monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older; and as preventative treatment of migraine in patients 12 years of age and older. Topiramate is one of Eton’s three neurology-focused oral liquid product candidates that have been submitted to the FDA, and all three product candidates are expected to be approved and launched in 2021.