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# Wyeth’s Cordarone Not Withdrawn Due to Safety/Effectiveness
- URL: https://www.fdaweb.com/wyeths-cordarone-not-withdrawn-due-to-safety-effectiveness/
- Published: 2017-08-16T12:00:00.000Z
- Updated: 2026-09-14T22:41:41.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139393

*Federal Register* notice: Responding to a citizen petition request, FDA has determined that Wyeth Pharmaceuticals’ Cordarone (amiodarone hydrochloride) tablets, 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency can approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. Cordarone is indicated for treating certain, life-threatening recurrent ventricular arrhythmias when they have not responded to other available antiarrhythmics or when alternative agents could not be tolerated. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-08-16/pdf/2017-17302.pdf?ref=fdaweb.com).