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Supernus Pharmaceuticals Inc Receives Tentative Approval for Trokendi XR


Monday, 10 Jun 2013 09:31am EDT 

Supernus Pharmaceuticals Inc announced that it has received a tentative approval letter from the Food & Drug Administration (the FD) 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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