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# Lotensin HCT Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/lotensin-hct-not-withdrawn-due-to-safety-efficacy/
- Published: 2018-02-16T12:00:00.000Z
- Updated: 2026-09-14T23:23:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140784

*Federal Register* notice: FDA has determined that U.S. Pharmaceutical Holdings’ Lotensin HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs referencing the product if all other legal and regulatory requirements are met. The determination request was submitted in an 8/2017 EAS Consulting Group citizen petition. To view the notice, click [here](http://fdaweb.com/login.php?sa=s¤tPage=1&searchWords=real+world+evidence&cate=&category=&searchCriteria=&matchingRules=exact&publishDate=&orderBy=PublishDate+desc&search=search&stid=%241%243x2.OO5.%24mNQXfrarbAL0JV9xOE%2FX20&ref=fdaweb.com).