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# Roche’s Endep Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/roches-endep-not-withdrawn-due-to-safety-efficacy/
- Published: 2022-09-19T12:00:00.000Z
- Updated: 2026-09-14T17:59:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152766

*Federal Register* notice: FDA has determined that Hoffmann-La Roche’s Endep (amitriptyline HCl) oral concentrate, 40 mg/mL was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the product if all legal and regulatory requirements are met. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-09-19/pdf/2022-20195.pdf?ref=fdaweb.com).