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Supernus Pharma Obtains FDA Approval For Oxtellar XR In Epilepsy - Quick Facts

Supernus Pharmaceuticals Inc. (SUPN) said that it received approval from the Food & Drug Administration for Oxtellar XR, a novel once-daily extended release formulation of oxcarbazepine (formerly known as SPN-804).

The approval letter stated that the FDA has completed its review of the application and that Oxtellar XR is approved effective October 19, 2012 for use as recommended in the agreed-upon labeling. The FDA granted a waiver for the pediatric study requirement for ages birth to one month and a deferral for submission of post-marketing assessments for children 1 month to 6 years of age. The post-marketing pharmacokinetic assessments are due in 2016 followed by clinical assessments in 2021.

Formerly known as SPN-804, Oxtellar XR is a novel once- daily extended release formulation of oxcarbazepine. Oxtellar XR™ is an antiepileptic drug (AED) indicated for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age. The recommended daily dose for adults is 1200 mg to 2400 mg once per day, and for children 6 to 17 years of age is 900mg to 1800mg depending on weight. The product will be available in 150mg, 300mg and 600 mg extended-release tablets.

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