Bumex

Treats edema associated with congestive heart failure, hepatic … the nephrotic syndrome. NDA 18225, held by Validus Pharms. Bumetanide.

As of Nov 13, 2026, NDA 18225 (Bumex), held by Validus Pharms, was first approved by FDA on Feb 28, 1983, with 26 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1983
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Jun 14, 1985	Supplement 2Efficacy (new indication or use)	Approved	None posted
Feb 28, 1983	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Bumex1MG · tablet;oral	Bumetanide	RxReference drug
Bumex0.5MG · tablet;oral	Bumetanide	RxReference drug
Bumex2MG · tablet;oral	Bumetanide	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Jan 17, 2024	Supplement 29Manufacturing	Approved	Label Letter
Aug 8, 2018	Supplement 28Labeling · Standard review	Approved	Label Letter
May 4, 2017	Supplement 26Labeling · Standard review	Approved	Letter Label
Sep 28, 2015	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 21, 2010	Supplement 24Labeling	Approved	Letter Label
May 13, 2003	Supplement 22Labeling · Standard review	Approved	Letter
Oct 29, 2002	Supplement 19Labeling · Standard review	Approved	Review Letter Label
Oct 29, 2002	Supplement 18Labeling · Standard review	Approved	Review Letter Label
Nov 9, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 24, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 6, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 10, 1998	Supplement 13Labeling · Standard review	Approved	None posted
Nov 20, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 12, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 21, 1993	Supplement 11Labeling · Standard review	Approved	None posted
Jun 11, 1991	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 1, 1991	Supplement 10Labeling	Approved	None posted
Aug 28, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 5, 1989	Supplement 6Labeling	Approved	None posted
Dec 10, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 18, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 6, 1985	Supplement 5Labeling	Approved	None posted
Jun 14, 1985	Supplement 2Efficacy (new indication or use)	Approved	None posted
Feb 9, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 29, 1983	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 28, 1983	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18225
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