Benicar

Treats hypertension. NDA 21286, held by Cosette. Olmesartan Medoxomil.

As of Nov 14, 2026, NDA 21286 (Benicar), held by Cosette, was first approved by FDA on Apr 25, 2002, with 23 approved supplements and 0 published complete response letters.

First approved: Apr 25, 2002
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, 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. There are no controlled trials demonstrating risk reduction with Benicar.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below


Feb 4, 2010	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 25, 2002	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

3 strengths and forms


Benicar5MG · tablet;oral	Olmesartan Medoxomil	RxReference drug
Benicar20MG · tablet;oral	Olmesartan Medoxomil	RxReference drug
Benicar40MG · tablet;oral	Olmesartan Medoxomil	RxReference drug

All 24 submissions, including labeling and manufacturing supplements


Oct 17, 2019	Supplement 40Labeling · Standard review	Approved	Label Letter
Nov 1, 2016	Supplement 36Labeling · Standard review	Approved	Letter Label
Jul 8, 2016	Supplement 35Manufacturing · Standard review	Approved	None posted
Jun 10, 2016	Supplement 34Manufacturing · Standard review	Approved	None posted
Oct 7, 2014	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 23, 2014	Supplement 32Labeling · Standard review	Approved	Label Letter
Jul 3, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 27, 2014	Supplement 31Labeling · Standard review	Approved	Letter Label
Jun 13, 2014	Supplement 30Labeling · Standard review	Approved	Letter Label
Jul 3, 2013	Supplement 27Labeling · Standard review	Approved	Label Letter
Feb 1, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 11, 2012	Supplement 26Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 25Labeling	Approved	Letter Label
Mar 29, 2012	Supplement 23Labeling	Approved	Letter Label
Feb 15, 2012	Supplement 21Labeling	Approved	Letter Label
Jun 6, 2011	Supplement 20Labeling	Approved	Letter Label
May 19, 2011	Supplement 19Labeling	Approved	Letter Label
Feb 4, 2010	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 26, 2007	Supplement 12Labeling · Standard review	Approved	Letter
Jul 13, 2005	Supplement 10Labeling · Standard review	Approved	Review Letter Label
Nov 12, 2004	Supplement 6Labeling · Standard review	Approved	Letter
Feb 12, 2003	Supplement 2Labeling · Standard review	Approved	Letter
Oct 25, 2002	Supplement 1Labeling · Standard review	Approved	Letter
Apr 25, 2002	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 21286
Drugs@FDA: Overview at FDA
Company: Cosette

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