The FDA has granted tentative approval to Supernus Pharmaceuticals's Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR (topiramate) to include prophylaxis of migraine headache in adults. The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity, which expires on March 28, 2017. Final approval may not be made effective until this exclusivity period has expired. The FDA also has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients age six and older, rather than age 10 and older. Supernus Pharmaceuticals is headquartered in Rockville, Maryland.
—Kimberly Williams