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# Excela Diltiazem Not Withdrawn for Safety/Efficacy
- URL: https://www.fdaweb.com/excela-diltiazem-not-withdrawn-for-safety-efficacy/
- Published: 2024-08-26T12:00:00.000Z
- Updated: 2026-09-14T14:39:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157647

*Federal Register* notice: FDA has determined that Exela Pharma Sciences’ diltiazem HCl in dextrose, 125mg/125mL and 250mg/250mL were not withdrawn from sale for safety or effectiveness reasons. The determination permits the agemcy to approve ANDAs that reference the products if all other legal and regulatory requirements are met. They are indicated for (**1**) temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter; and (**2**) rapid conversion of paroxysmal supraventricular tachycardias to sinus rhythm. To view the notice, click [here](https://public-inspection.federalregister.gov/2024-19233.pdf?ref=fdaweb.com).