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Eton Pharmaceuticals, Inc a specialty pharmaceutical company focused on developing and commercializing innovative drug products, announced it has submitted a new drug application (NDA) for zonisamide oral suspension, previously known as the company’s ET 104 product candidate, to the FDA for the treatment of partial seizures in patients with epilepsy.
Zonisamide is indicated as: • monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1); • adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.
Zonisamide Capsules is indicated as: - monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1). - adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.