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# Onfi Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/onfi-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2019-04-03T12:00:00.000Z
- Updated: 2026-09-15T01:18:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143775

*Federal Register* notice: FDA has determined that Lundbeck Pharmaceuticals’ Onfi (clobazam) tablets 5mg were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the drug product, if all other legal and regulatory requirements are met. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-04-02/pdf/2019-06381.pdf?ref=fdaweb.com).