Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution
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.
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Source: Eton Pharmaceuticals