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# Novartis’ Serentil Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/novartis-serentil-not-withdrawn-due-to-safety-efficacy/
- Published: 2021-04-01T12:00:00.000Z
- Updated: 2026-09-14T16:53:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149018

*Federal Register* notice: FDA has determined that Novartis’ Serentil (mesoridazine besylate) tablets 10 mg, 25 mg, 50 mg, and 100 mg were not withdrawn from sale for safety or effectiveness reasons. Serentil is indicated for managing schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-04-01/pdf/2021-06721.pdf?ref=fdaweb.com).