Lotensin

Treats hypertension. NDA 19851, held by Validus Pharms. Benazepril Hydrochloride.

As of Nov 13, 2026, NDA 19851 (Lotensin), held by Validus Pharms, was first approved by FDA on Jun 25, 1991, with 44 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1991
Review: Standard
Supplements approved: 44
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Lotensin is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 45 submissions below


Mar 2, 2004	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 25, 1991	Original applicationNew molecular entity · Standard review	Approved	Pediatric Written Request Pediatric Amendment 1 Pediatric Medical Review Pediatric Clinical Pharmacology Review

Products

4 strengths and forms


Lotensin5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Benazepril Hydrochloride	DiscontinuedReference drug
Lotensin10MG · tablet;oral	Benazepril Hydrochloride	RxReference drug
Lotensin20MG · tablet;oral	Benazepril Hydrochloride	RxReference drug
Lotensin40MG · tablet;oral	Benazepril Hydrochloride	RxReference drug

All 45 submissions, including labeling and manufacturing supplements


Jan 7, 2019	Supplement 54Labeling · Standard review	Approved	Letter Label
Aug 3, 2017	Supplement 52Labeling · Standard review	Approved	Label Letter
Dec 17, 2015	Supplement 50Manufacturing · Standard review	Approved	None posted
Jul 22, 2015	Supplement 49Labeling · Standard review	Approved	Label Letter
Jul 22, 2015	Supplement 45Labeling · Standard review	Approved	Label Letter
Jul 14, 2015	Supplement 48Manufacturing · Standard review	Approved	None posted
Jan 26, 2015	Supplement 47Labeling · Standard review	Approved	Label Letter
Dec 12, 2014	Supplement 46Labeling · Standard review	Approved	Label Letter
Sep 21, 2012	Supplement 44Labeling	Approved	Label
May 17, 2012	Supplement 42Labeling	Approved	Label Letter
Jan 19, 2012	Supplement 43Labeling	Approved	Letter Label
Jun 14, 2011	Supplement 40Labeling	Approved	Letter Label
Nov 10, 2009	Supplement 38Labeling · Standard review	Approved	Letter Label
Jan 22, 2009	Supplement 37Labeling · Standard review	Approved	Letter
May 29, 2008	Supplement 36Labeling · Standard review	Approved	Letter
Feb 2, 2007	Supplement 34Labeling · Standard review	Approved	Letter
Mar 2, 2004	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 29, 2003	Supplement 29Labeling · Standard review	Approved	Letter
Oct 25, 2002	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 20, 2002	Supplement 25Manufacturing · Standard review	Approved	None posted
Apr 29, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 14, 2001	Supplement 21Labeling · Standard review	Approved	None posted
Nov 30, 2001	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 13, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
Nov 2, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
May 10, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 28, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 29, 1998	Supplement 16Labeling · Standard review	Approved	None posted
Jul 20, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 13, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 18, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 13, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 25, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 22, 1995	Supplement 9Labeling · Standard review	Approved	None posted
Nov 2, 1995	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 7, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
May 5, 1995	Supplement 7Labeling · Standard review	Approved	None posted
Feb 8, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 15, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 21, 1993	Supplement 5Labeling · Standard review	Approved	None posted
Nov 20, 1992	Supplement 4Labeling · Standard review	Approved	None posted
Jun 25, 1992	Supplement 3Labeling	Approved	None posted
Mar 13, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 9, 1992	Supplement 1Labeling	Approved	None posted
Jun 25, 1991	Original applicationNew molecular entity · Standard review	Approved	Pediatric Written Request Pediatric Amendment 1 Pediatric Medical Review Pediatric Clinical Pharmacology Review

Identifiers

Application: NDA 19851
Drugs@FDA: Overview at FDA
Company: Validus Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters