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.
"We are very excited about the approval of Trokendi XR and its upcoming launch," Supernus president, director and CEO Jack Khattar said. "This is excellent news for Supernus, its shareholders and patients with epilepsy. We remain committed to the epilepsy community and very much look forward to now having two products, Trokendi XR and Oxtellar XR, available to patients."
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