Supernus Pharmaceuticals (SUPN) Receives Tentative FDA Approval
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Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) received a tentative approval letter from 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. Our initial understanding is that final approval is conditioned on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.
The letter states that the FDA completed its review of the Trokendi XR NDA and that no additional clinical trials are required. Our 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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