Supernus Pharmaceuticals, Inc. (SUPN) said it received a tentative approval letter from the FDA for Trokendi XR, a once-daily extended release formulation of topiramate.
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.
"We are pleased to announce that the FDA granted us tentative approval for Trokendi XR and that all of the scientific and procedural conditions for approval have been met. We will continue to work closely with the FDA to further understand the outstanding issue and move forward towards final approval," said Jack Khattar, Chief Executive Officer, President and Director of Supernus.
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