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FDA approves Supernus epilepsy drug
ROCKVILLE, Md. — The Food and Drug Administration has approved a new epilepsy drug made by Supernus Pharmaceuticals, the company said Monday.
Supernus announced the approval of Trokendi XR, a once-daily, extended-release formulation of the drug topiramate. As part of the approval, the FDA granted Supernus a waiver for some of the requirements for studies of the drug in children and a deferral for submission of other post-marketing data due in 2019, followed by clinical assessments in 2025.