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Supernus Pharmaceuticals Obtains Final Approval From FDA For Trokendi XR

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8/19/2013 7:39 AM ET

Supernus Pharmaceuticals Inc. (SUPN: Quote) said Monday that it received final approval from the Food & Drug Administration or the "FDA" for Trokendi XR, a novel once-daily extended release formulation of topiramate for the treatment of epilepsy. The company noted that it expects to launch the product and for it to be available in pharmacies over the next few weeks.

The company stated that the FDA granted a waiver for certain pediatric study requirements and a deferral for submission of post-marketing pediatric pharmacokinetic assessments that are due in 2019 followed by clinical assessments in 2025.

Trokendi XR is an antiepileptic drug indicated for initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures, and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.

The company noted that the product will be available in 25mg, 50mg, 100mg and 200mg extended-release capsules.

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by RTT Staff Writer

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