> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Grants Supernus Tentative Approval on Trokendi
- URL: https://www.fdaweb.com/fda-grants-supernus-tentative-approval-on-trokendi/
- Published: 2016-08-19T12:00:00.000Z
- Updated: 2026-09-14T21:25:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136563

FDA has granted Supernus Pharmaceuticals tentative approval for an sNDA requesting a label expansion for Trokendi (topiramate) XR to include preventing migraine headache in adults. The tentative approval is based on an outstanding pediatric exclusivity period which expires 3/28/2017\. Additionally, the agency granted final approval to expand the drug’s label for monotherapy treatment of partial onset seizures to include adults and pediatric patients six years and older, a broader patient population than the previous 10 years and older. The product is available in 25mg, 50mg, 100mg and 200mg extended-release capsules.