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# Topamax Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/topamax-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-02-22T12:00:00.000Z
- Updated: 2026-09-14T18:16:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153828

*Federal Register* notice: FDA has determined that Janssen’s Topamax (topiramate) sprinkle capsules, 50 mg, was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for topiramate sprinkle capsules if all other legal and regulatory requirements are met. Topamax is indicated for treating certain patients with epilepsy, and preventing migraines in patients 12 years of age and older. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-02-21/pdf/2023-03516.pdf?ref=fdaweb.com).