Posted by Michael Wonder on 07 Oct 2020
Eton Pharmaceuticals submits new drug application to the FDA for topiramate oral solution
6 October 2020 - Application submitted for the treatment of partial-onset seizures and migraine.
Eton Pharmaceuticals today announced that in tandem with its development and manufacturing partner Tulex Pharmaceuticals, it has submitted a new drug application for topiramate oral solution to the U.S. FDA.
The product candidate, formerly known as ET-101, 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.
