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Supernus Announces FDA Acceptance of sNDA to Add Migraine to Trokendi XR Label


Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) announced today that the United States Food and Drug Administration (FDA) has accepted for review the company's supplemental new drug application (sNDA) for Trokendi XR®. The application requests FDA approval to expand the indication for Trokendi XR beyond the current indication for the treatment of epilepsy to include treatment for adults for prophylaxis of migraine headache. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set a target date in the second quarter of 2016 to complete its review.

"Now that our application is under review, we look forward to working with the FDA to ensure a timely approval of the new indication," said Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals. "If approved for use in migraine, Trokendi XR would represent an important new treatment option for adult patients suffering from this condition."

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. The Company markets two products for epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR® (extended-release topiramate). The Company is also developing several product candidates

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Posted-In: News FDA Press Releases


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