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FDA Tentatively Approves Supernus Pharma's Epilepsy Drug Supernus

Supernus Pharmaceuticals, Inc (SUPN), a developer of products to treat central nervous system, Monday said it received a tentative approval letter from the Food & Drug Administration or FDA for its epilepsy drug Trokendi XR. The product is tentatively approved for use as recommended in the submitted and agreed-upon labeling. Trokendi XR formerly known as SPN-538 is a novel once-daily extended release formulation of topiramate.

"We will now submit the "Request for Final Approval" letter to the FDA based on which we expect to receive Final Approval and then launch our product, as anticipated, in the third quarter of 2013," said Jack Khattar, chief executive officer.

by RTT Staff Writer

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