Supernus Pharmaceuticals, Inc. (SUPN) is gaining ground in pre-market trading on Tuesday. The advance comes after the company received a tentative approval letter from the FDA for Trokendi XR, a once-daily extended release formulation of topiramate.
Shares of Supernus are up $1.78, or 31.2%, to $7.49.
The letter stated that the FDA completed its review of the Trokendi XR NDA and that no additional clinical trials are required. Supernus said its 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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