Mefenamic acid

Overview

A non-steroidal anti-inflammatory agent with analgesic, anti-inflammatory, and antipyretic properties. It is an inhibitor of cyclooxygenase.

Indication

For the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea, and mild to moderate pain, inflammation, and fever.

Associated Conditions

Mild pain
Primary Dysmenorrhoea
Gastrointestinal cramping
Moderate Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Management of Abnormal Uterine Bleeding	2024/04/16	NCT06369012	Not Applicable	Completed	Egymedicalpedia
A Trial Investigating Lu AF28996 in Healthy Adult Participants	2024/02/26	NCT06277609	Phase 1	Completed	H. Lundbeck A/S
A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults	2021/10/01	NCT05064449	Phase 1	Completed	Takeda
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite	2021/05/26	NCT04902105	Phase 1	Completed	Emalex Biosciences Inc.
Preemptive Analgesia for Primary Dysmenorrhoea	2017/10/27	NCT03323671	Phase 2	Completed	Hanan Nabil
Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects	2017/03/03	NCT03070678	Phase 1	Completed	Sanofi
Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause	2016/10/25	NCT02943655	Phase 3	Completed	Assiut University
Efficacy of Different Drugs to Control Post Root Canal Treatment Pain	2015/04/15	NCT02417337	Phase 2	Completed	University of Khartoum
Efficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea	2014/07/08	NCT02183025	Phase 2	Completed	Boehringer Ingelheim
DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis	2013/09/13	NCT01942122	Phase 2	Completed	Dexa Medica Group

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Mefenamic acid	Micro Labs Limited	42571-258	ORAL	250 mg in 1 1	1/12/2023
Mefenamic Acid	Belcher Pharmaceuticals,LLC	62250-677	ORAL	250 mg in 1 1	10/5/2023
Mefenamic Acid	Advanced Rx Pharmacy of Tennessee, LLC	80425-0306	ORAL	250 mg in 1 1	4/6/2023
Mefenamic Acid	Misemer Pharmaceuticals, Inc	0276-0509	ORAL	250 mg in 1 1	12/13/2022
Mefenamic Acid	Lupin Pharmaceuticals, Inc.	68180-185	ORAL	250 mg in 1 1	1/19/2024

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
PONTALON FILM COATED TABLET 500 mg	Y S P INDUSTRIES (M) SDN BHD	SIN07726P	TABLET, FILM COATED	500 mg	5/19/1994
FENAGESIC-500 TABLET 500 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN05718P	TABLET, FILM COATED	500 mg	4/8/1991
BEAFEMIC CAPSULES 250 mg	BEACONS PHARMACEUTICALS PTE. LTD.	SIN05376P	CAPSULE	250 mg	1/29/1991
ORCIGESIC TABLETS	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN06047P	TABLET, FILM COATED	250 mg	5/24/1991
FENAGESIC SUSPENSION 125 mg/5 ml	SUNWARD PHARMACEUTICAL PRIVATE LIMITED, SUNWARD PHARMACEUTICAL SDN BHD	SIN05488P	SUSPENSION	125 mg/5 ml	2/19/1991
MEFRIL-250 CAPSULE 250 mg	MICRO LABS LTD	SIN10125P	CAPSULE	250 mg	10/2/1998
MEDICAP CAPSULE 250 mg	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN05454P	CAPSULE	250 mg	2/19/1991
FENAGESIC TABLETS 250 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN05717P	TABLET, FILM COATED	250 mg	4/8/1991
PONTALON CAPSULE 250 mg	Y S P INDUSTRIES (M) SDN BHD	SIN08483P	CAPSULE	250 mg	12/16/1995
FENAGESIC CAPSULES 250 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN05487P	CAPSULE	250 mg	2/19/1991

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
MEFENAMIC ACID CAP 250MG	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	4/26/1979
ELOKWEI MEFENAMIC ACID TABLETS 500MG	N/A	WELLDONE PHARMACEUTICALS LIMITED	N/A	N/A	11/11/2024
SHUTON CAPSULES 250MG	N/A	WELLDONE PHARMACEUTICALS LIMITED	N/A	N/A	9/13/2024
EFORMAT MEFENAMIC ACID TABLETS 500MG	N/A	WELLDONE PHARMACEUTICALS LIMITED	N/A	N/A	11/11/2024
PRESITON TABLETS 250MG	N/A	WELLDONE PHARMACEUTICALS LIMITED	N/A	N/A	12/10/2019
MEFENAM CAPSULES 250MG	N/A	HITPHARM PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	12/31/2015
METSYN CAP 250MG	N/A	synco (h.k.) limited	N/A	N/A	10/6/2016
TOEEFON TAB 250MG.	N/A	VAST RESOURCES PHARMACEUTICAL LIMITED	N/A	N/A	3/15/2008
SUITONE TABLETS 500MG	N/A	WELLDONE PHARMACEUTICALS LIMITED	N/A	N/A	11/11/2024
PONSGESIC CAP 250MG	N/A	AMERICAN UNICORN LABORATORIES LIMITED	N/A	N/A	10/18/1983

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PONSTAN mefenamic acid 250mg capsule blister pack	225658	Pfizer Australia Pty Ltd	Medicine	A	7/29/2014
MENAMIC MLabs mefenamic acid 250 mg capsule bottle	275275	Micro Labs Pty Ltd	Medicine	A	7/7/2017
FEMIN mefenamic acid 250mg capsule bottle	275277	Luminarie Pty Ltd	Medicine	A	7/7/2017
PONSTAN mefenamic acid 250mg capsule blister pack	14388	Pfizer Australia Pty Ltd	Medicine	A	9/20/1991
MENOPAIN mefenamic acid 250mg capsule bottle	301376	Micro Labs Pty Ltd	Medicine	A	3/28/2018
MEFENAMIC ACID MLabs mefenamic acid 250 mg capsule bottle	275276	Micro Labs Pty Ltd	Medicine	A	7/7/2017
MEFENAMIC ACID MLPL mefenamic acid 250mg capsule bottle	275274	Micro Labs Pty Ltd	Medicine	A	7/7/2017
FEMIN mefenamic acid 250 mg capsule bottle	301375	Luminarie Pty Ltd	Medicine	A	3/28/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MEFENAMIC ACID	Apotex Inc	02229569	Capsule - Oral	250 MG	N/A
PONSTAN	aa pharma inc	00155225	Capsule - Oral	250 MG	12/31/1966
MEFENAMIC-250	PRO DOC LIMITEE	02230408	Capsule - Oral	250 MG	8/6/1997
DOM-MEFENAMIC ACID	dominion pharmacal	02237826	Capsule - Oral	250 MG	9/17/1998
PMS-MEFENAMIC ACID	Pharmascience Inc	02231208	Capsule - Oral	250 MG	4/16/1998
NOVO-MEFENAMIC CAPSULES 250MG	novopharm limited	02239836	Capsule - Oral	250 MG	N/A
MEFENAMIC	aa pharma inc	02229452	Capsule - Oral	250 MG	11/6/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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.

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