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Supernus Pharmaceuticals Inc Receives Tentative Approval of Trokendi XR From FDA


Tuesday, 26 Jun 2012 08:00am EDT 

Supernus Pharmaceuticals Inc announced that it has received a tentative approval letter from the Food & Drug Administration (the FDA) for Trokendi XR, a 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 NDA and that no additional clinical trials are required. The initial understanding is that final approval is conditioned on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population. 

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