FDA issues tentative approval of expanded Trokendi XR label for migraine prevention

Supernus Pharmaceuticals Inc. has received tentative approval for an expanded label for Trokendi XR that includes migraine prophylaxis in adults, according to a press release issued by the company.

The FDA's tentative approval of the Supplemental New Drug Application is an indication that the drug has met all required quality, safety and efficacy standards.

Trokendi XR (topiramate) is under pediatric exclusivity until March 28, 2017, however, and final approval may not be issued until after this period, the company stated.

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

Supernus Pharmaceuticals also announced final approval of a label expansion for Trokendi XR as monotherapy treatment for partial-onset seizures. The label was expanded from patients aged 10 years and older to include patients aged 6 years and older.