Exforge

Treats hypertension. NDA 21990, held by Novartis. Amlodipine Besylate; Valsartan.

As of Nov 13, 2026, NDA 21990 (Exforge), held by Novartis, was first approved by FDA on Jun 20, 2007, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 20, 2007
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Exforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Exforge is indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled on monotherapy As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jul 23, 2008	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 20, 2007	Original applicationNew combination · Standard review	Approved	Review Letter Label Letter

Products

4 strengths and forms


ExforgeEQ 5MG BASE;160MG · tablet;oral	Amlodipine Besylate; Valsartan	RxReference drug
ExforgeEQ 10MG BASE;160MG · tablet;oral	Amlodipine Besylate; Valsartan	RxReference drug
ExforgeEQ 5MG BASE;320MG · tablet;oral	Amlodipine Besylate; Valsartan	RxReference drug
ExforgeEQ 10MG BASE;320MG · tablet;oral	Amlodipine Besylate; Valsartan	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Apr 7, 2021	Supplement 41Labeling · Standard review	Approved	Label Letter
Jun 12, 2019	Supplement 33Labeling · Standard review	Approved	Letter Label
Feb 12, 2016	Supplement 28Manufacturing · Standard review	Approved	None posted
Dec 21, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 28, 2015	Supplement 26Labeling · Standard review	Approved	Letter Label
May 22, 2015	Supplement 25Manufacturing · Standard review	Approved	None posted
Sep 24, 2014	Supplement 24Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 17, 2014	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 17, 2014	Supplement 20Labeling · Standard review	Approved	Letter
Nov 28, 2012	Supplement 19Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 18Labeling	Approved	Letter Label
Jan 18, 2012	Supplement 17Labeling	Approved	Label Letter
Dec 7, 2011	Supplement 14Labeling	Approved	Letter Label
Oct 31, 2011	Supplement 16Labeling	Approved	Letter Label
May 31, 2011	Supplement 13Labeling	Approved	Label Letter
Mar 30, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Jul 23, 2008	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Jun 20, 2007	Original applicationNew combination · Standard review	Approved	Review Letter Label Letter

Identifiers

Application: NDA 21990
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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