> ## 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 Approves 2 Upsher-Smith sNDAs for Migraine Drug
- URL: https://www.fdaweb.com/fda-approves-2-upsher-smith-sndas-for-migraine-drug/
- Published: 2017-03-30T12:00:00.000Z
- Updated: 2026-09-14T22:14:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138340

FDA has approved two Upsher-Smith Laboratories supplemental NDAs for Qudexy XR (topiramate) Extended-Release Capsules for use in preventing migraine headache in adults and adolescents 12 years of age and older. Topiramate is the active ingredient in Janssen Pharmaceuticals’ Topamax (**topiramate**) and is the molecule that neurologists prescribe most frequently for the prevention of migraines, according to the company.

  
Qudexy XR has been engineered to deliver a level pharmacokinetic profile and was shown to reduce the peak-to-trough fluctuation of topiramate plasma concentrations that are associated with immediate-release topiramate, the company says. Upsher-Smith has also agreed to address post-marketing requirements with a study to evaluate the efficacy and safety of Qudexy XR for preventing migraine in pediatric patients aged 6-11.