Supernus (SUPN) Receives Tentative FDA Approval of Trokendi XR
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Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) 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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