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# Zonegran Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/zonegran-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2019-08-22T12:00:00.000Z
- Updated: 2026-09-15T01:45:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144833

*Federal Register* notice: FDA has determined that Sunovion Pharmaceuticals’ Zonegran (zonisamide) capsules, 50mg, were not withdrawn for safety or effectiveness reasons. The determination means that FDA will continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. The drug is indicated as adjunctive therapy in treating partial seizures in adults with epilepsy. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-08-22/pdf/2019-18089.pdf?ref=fdaweb.com).