Nabumetone

Overview

Nabumetone was originally developed as a non-acidic non-steroidal anti-inflammatory drug (NSAID). It was thought to avoid trapping of the drug in the stomach by making it unable to dissociate into ions which was believed to reduce GI toxicity by limiting local action. While slightly reduced, possibly due to a degree of cyclooxygenase-2 selectivity (COX-2), nabumetone still produces significant adverse effects in the GI tract. The molecule itself is a pro-drug with its 6-methoxy-2-naphthylacetic acid (6-MNA) metabolite acting as a potent COX inhibitor similar in structure to naproxen. Nabumetone was developed by Smithkline Beecham under the trade name Relafen and first received FDA approval in December, 1991.

Indication

Indicated for: 1) Symptomatic relief in rheumatoid arthritis. 2) Symptomatic relief in osteoarthritis.

Associated Conditions

Osteoarthritis (OA)
Rheumatoid Arthritis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fed Conditions	2010/07/19	NCT01164826	Phase 1	Completed	Dr. Reddy's Laboratories Limited
Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting Conditions	2010/07/19	NCT01164813	Phase 1	Completed	Dr. Reddy's Laboratories Limited
Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers	2009/03/19	NCT00864968	Phase 1	Completed	Actavis Inc.
Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers	2009/03/19	NCT00864604	Phase 1	Completed	Actavis Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nabumetone	Unit Dose Services	50436-6046	ORAL	500 mg in 1 1	4/1/2015
Nabumetone	ScieGen Pharmaceuticals Inc	50228-465	ORAL	500 mg in 1 1	2/2/2022
Nabumetone	Bryant Ranch Prepack	71335-2292	ORAL	500 mg in 1 1	2/2/2022
Nabumetone	Bryant Ranch Prepack	71335-0754	ORAL	750 mg in 1 1	2/27/2019
Nabumetone	H.J. Harkins Company, Inc.	52959-650	ORAL	500 mg in 1 1	12/20/2011
Nabumetone	Amneal Pharmaceuticals of New York LLC	0115-1658	ORAL	750 mg in 1 1	4/22/2019
Nabumetone	Bryant Ranch Prepack	72162-1557	ORAL	500 mg in 1 1	2/8/2024
Nabumetone	Chartwell RX, LLC	62135-146	ORAL	750 mg in 1 1	1/20/2023
Nabumetone	Proficient Rx LP	71205-030	ORAL	500 mg in 1 1	12/1/2022
Nabumetone	RxChange Co.	33358-252	ORAL	750 mg in 1 1	11/13/2014

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SANDOZ NABUMETONE	Sandoz Canada, Inc.	02242912	Tablet - Oral	500 MG	2/21/2002
RELAFEN TABLETS 750MG	GlaxoSmithKline Inc	02083558	Tablet - Oral	750 MG	1/29/1998
PMS-NABUMETONE	Pharmascience Inc	02238760	Tablet - Oral	750 MG / TAB	N/A
MYLAN-NABUMETONE	Mylan Pharmaceuticals ULC	02244563	Tablet - Oral	500 MG	2/20/2002
TEVA-NABUMETONE	teva canada limited	02240868	Tablet - Oral	750 MG	5/18/2000
NABUMETONE	Apotex Inc	02238369	Tablet - Oral	500 MG	N/A
TEVA-NABUMETONE	teva canada limited	02240867	Tablet - Oral	500 MG	3/8/2000
NABUMETONE-500	PRO DOC LIMITEE	02239113	Tablet - Oral	500 MG	4/7/2008
RELAFEN TABLETS 500MG	GlaxoSmithKline Inc	02083531	Tablet - Oral	500 MG	12/31/1994
PMS-NABUMETONE	Pharmascience Inc	02238759	Tablet - Oral	500 MG / TAB	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
RELIF 1000 MG COMPRIMIDOS DISPERSABLES	Viatris Healthcare Limited	59395	COMPRIMIDO DISPERSABLE	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access