FDA grants tentative approval to Supernus sNDA for Trokendi XR

Supernus Pharmaceuticals Inc. recently reported that its Supplemental New Drug Application (sNDA) that requested an expansion to the label of Trokendi XR to include prophylaxis for migraine headaches in adults has been granted tentative approval by the U.S. Food and Drug Administration (FDA).

The FDA gave tentative approval of Supernus’ sNDA due to the drug’s exclusivity to pediatrics, which expires in March of next year. The FDA did find that the drug does meet all of the required quality, safety and efficiency standards for approval.

“We will continue to work with the FDA to gain final approval upon the expiration of pediatric exclusivity,” Supernus Pharmaceuticals President and CEO Jack Khattar said. “We are prepared and ready to launch the migraine indication upon receiving full FDA approval.”

The FDA has granted final approval on the expansion of the label for Trokendi XR as a single treatment therapy for partial onset seizures to include adult patients and pediatrics six years of age and older.