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18 Dec 2018

US FDA approves Supernus’ sNDA to expand Oxtellar XR label

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Supernus Pharmaceuticals, Inc. announced that the United States Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for Oxtellar XR. The application requested FDA approval to expand the indication for Oxtellar XR beyond the current indication of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age.

“We are pleased with the timely approval of the expanded indication for Oxtellar XR. We look forward to launching Oxtellar XR in the first quarter 2019 as a new monotherapy treatment option for partial-onset seizures. We believe that expanding the indication to include monotherapy represents an additional growth opportunity for Oxtellar XR,” said Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals.

Oxtellar XR is the first approved novel, oral once-daily extended release formulation of oxcarbazepine for the treatment of partial-onset seizures in patients 6 years of age and older. The product is available in 150mg, 300mg, and 600mg extended-release tablets.

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