Edarbi

Treats hypertension. NDA 200796, held by Azurity. Azilsartan Kamedoxomil.

As of Nov 14, 2026, NDA 200796 (Edarbi), held by Azurity, was first approved by FDA on Feb 25, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2011
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Edarbi is indicated for the treatment of hypertension in adults, 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 Edarbi.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 25, 2011	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


EdarbiEQ 40MG MEDOXOMIL · tablet;oral	Azilsartan Kamedoxomil	RxReference drug
EdarbiEQ 80MG MEDOXOMIL · tablet;oral	Azilsartan Kamedoxomil	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Jan 16, 2024	Supplement 13Labeling · Standard review	Approved	Label Letter
Mar 6, 2020	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 24, 2016	Supplement 9Labeling · Standard review	Approved	Letter
Mar 24, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 23, 2014	Supplement 6Labeling · Standard review	Approved	Letter Label
Apr 18, 2014	Supplement 5Labeling · Standard review	Approved	Letter
Jul 29, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 4, 2012	Supplement 3Labeling	Approved	Label Letter
Dec 14, 2011	Supplement 2Labeling	Approved	Letter Label
Apr 12, 2011	Supplement 1Labeling	Approved	Letter Label
Feb 25, 2011	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 200796
Drugs@FDA: Overview at FDA
Company: Azurity 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