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# AstraZeneca’s Elavil Not Withdrawn Due to Safety/Effectiveness
- URL: https://www.fdaweb.com/astrazenecas-elavil-not-withdrawn-due-to-safety-effectiveness/
- Published: 2017-10-23T12:00:00.000Z
- Updated: 2026-09-14T22:57:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139943

*Federal Register* notice: FDA has determined that AstraZeneca’s Elavil (amitriptyline hydrochloride) oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs if all other legal and regulatory requirements are met. The action was requested by Alembic Pharmaceuticals Limited in a June citizen petition. Elavil is indicated for the relief of symptoms of depression. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-23/pdf/2017-22892.pdf?ref=fdaweb.com).