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# K-TAB Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/k-tab-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-08-04T12:00:00.000Z
- Updated: 2026-09-14T18:48:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155028

*Federal Register* notice: FDA has determined that K–TAB (potassium chloride) extended-release tablets were not withdrawn due to safety or effectiveness concerns. The determination will allow the agency to approve ANDAs for potassium chloride extended-release tablets if all other legal and regulatory requirements are met. FDA may not approve an ANDA that does not refer to a listed drug. K–TAB was originally approved in 1980 and the NDA is currently held by AbbVie. The drug is indicated for the treatment and prophylaxis of hypokalemia in patients whose dietary management with potassium-rich foods or diuretic dose reduction is insufficient. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-08-03/pdf/2023-16537.pdf?ref=fdaweb.com).