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# Prexxartan Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/prexxartan-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2020-09-23T12:00:00.000Z
- Updated: 2026-09-14T16:29:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147719

*Federal Register* notice: FDA has determined that Carmel Biosciences’ Prexxartan (valsartan) oral solution, 20 mg/5mL and 80 mg/20 mL, were not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the if all other legal and regulatory requirements are met. Prexxartan is indicated for hypertension in adults and children six years and older to lower blood pressure. It is also used for heart failure by significantly reducing hospitalization for patients who are unable to swallow valsartan tablets, and for stable left ventricular failure or left ventricular dysfunction following myocardial infarction. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-09-23/pdf/2020-20965.pdf?ref=fdaweb.com).