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# Metaxalone not Withdrawn Due to Safety/Effectiveness: FDA
- URL: https://www.fdaweb.com/metaxalone-not-withdrawn-due-to-safety-effectiveness-fda/
- Published: 2018-07-27T12:00:00.000Z
- Updated: 2026-09-15T00:22:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141977

*Federal Register* notice: FDA has determined that metaxalone tablets, 640 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The determination was made in response to a 3/26 Sovereign Pharmaceuticals citizen petition. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-27/pdf/2018-16031.pdf?ref=fdaweb.com).