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  • Topiramate oral solution is accepted for filing by...

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

Read time: 1 mins
Published:18th Dec 2020
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.
Condition: Epilepsy
Type: drug

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