BioCentury
ARTICLE | Clinical News

Trokendi XR topiramate regulatory update

September 5, 2016 7:00 AM UTC

FDA granted final approval to an sNDA from Supernus for Trokendi XR topiramate as monotherapy treatment of partial onset seizures in patients ages 6-9. The drug is approved for the indication in patients ages >=10. The agency also granted tentative approval to an sNDA for the product to prevent migraines in adults. The company expects to receive final approval when pediatric exclusivity for immediate-release Trokendi topiramate from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) expires on March 28, 2017. Trokendi XR is also approved as adjunctive therapy in patients ages >=6 with partial onset or primary generalized tonic-clonic seizures or with seizures associated with Lennox-Gastaut syndrome. ...