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Supernus Pharmaceuticals (SUPN) Receives Tentative Approval for Trokendi XR™


6/10/2013 9:16:09 AM

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ROCKVILLE, Md., June 10, 2013 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceutical company, received a tentative approval letter from the Food & Drug Administration (the "FDA") for Trokendi XR™, a novel once-daily extended release formulation of topiramate (formerly known as SPN-538). The letter states that the FDA completed its review of the Trokendi XR™ New Drug Application (the "NDA") as amended in December 2012 and the product is tentatively approved for use as recommended in the submitted and agreed-upon labeling.

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