Meloxicam

Overview

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve various types of pain, including pain caused by musculoskeletal conditions, osteoarthritis, and rheumatoid arthritis. With a longer half-life than most other NSAIDS, it is a favorable option for those who require once-daily dosing. Meloxicam is available in oral, transdermal, and intravenous formulations. It is a preferential COX-2 inhibitor, purportedly reducing the risk of adverse gastrointestinal tract effects, however, this is a topic of controversy.

Indication

Meloxicam is indicated for the symptomatic treatment of arthritis and osteoarthritis. In addition, it is indicated for the pauciarticular and polyarticular course of Juvenile Rheumatoid Arthritis (JRA) in patients aged 2 years old or above. Off-label uses include the treatment of dental or post-surgical pain. In addition to the above, meloxicam has also been studied in the treatment of neuropathic pain. Meloxicam, in combination with bupivacaine, is indicated for postsurgical analgesia in adult patients for up to 72 hours following foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

Associated Conditions

Dental Pain
Neuropathic Pain
Osteoarthritis (OA)
Pain, Inflammatory
Pauciarticular juvenile rheumatoid arthritis
Polyarticular juvenile rheumatoid arthritis, chronic or unspecified
Postoperative pain
Rheumatoid Arthritis

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery	2009/07/24	NCT00945763	Phase 2	Completed	Alkermes, Inc.
Meloxicam 15 mg Tablets Under Non-Fasting Conditions	2009/02/10	NCT00840879	Phase 1	Completed	Teva Pharmaceuticals USA
Meloxicam 15 mg Tablets Under Fasting Conditions	2009/02/10	NCT00840476	Phase 1	Completed	Teva Pharmaceuticals USA
Food Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg	2008/04/01	NCT00649675	Phase 1	Completed	Mylan Pharmaceuticals Inc
Fasting Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg	2008/04/01	NCT00649077	Phase 1	Completed	Mylan Pharmaceuticals Inc
A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis	2008/03/13	NCT00635349	Phase 4	Completed	Janssen Korea, Ltd., Korea
Bioequivalency Study of Meloxicam Tablets Under Fasting Conditions	2008/02/18	NCT00618163	Not Applicable	Completed	Roxane Laboratories
Bioequivalency Study of Meloxicam Tablets Under Fed Conditions	2008/01/28	NCT00601887	Not Applicable	Completed	Roxane Laboratories
A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)	2006/01/20	NCT00279747	Phase 3	Completed	Boehringer Ingelheim
A Study to Compare Meloxicam IM Once Daily and Meloxicam Administered Orally Once Daily in Patients With Osteoarthritis	2005/10/17	NCT00239395	Phase 3	Completed	Boehringer Ingelheim

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Meloxicam	Exelan Pharmaceuticals Inc.	76282-152	ORAL	7.5 mg in 1 1	2/17/2023
MELOXICAM	Proficient Rx LP	82804-029	ORAL	15 mg in 1 1	12/1/2023
Meloxicam	Bryant Ranch Prepack	72162-1738	ORAL	15 mg in 1 1	2/6/2024
meloxicam	Bryant Ranch Prepack	71335-1618	ORAL	15 mg in 1 1	2/10/2022
meloxicam	REMEDYREPACK INC.	70518-0039	ORAL	7.5 mg in 1 1	4/18/2025
Meloxicam	MedVantx, Inc.	66116-393	ORAL	15 mg in 1 1	2/18/2013
meloxicam	REMEDYREPACK INC.	70518-0031	ORAL	7.5 mg in 1 1	4/18/2025
Meloxicam	Chartwell RX, LLC	62135-716	ORAL	15 mg in 1 1	10/13/2023
meloxicam	Aphena Pharma Solutions - Tennessee, LLC	71610-580	ORAL	15 mg in 1 1	8/6/2021
meloxicam	New Horizon Rx Group, LLC	58517-260	ORAL	15 mg in 1 1	12/30/2013

EMA Drug Approvals

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

HSA Drug Approvals

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

NMPA Drug Approvals

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

PPB Drug Approvals

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

TGA Drug Approvals

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

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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

UK EMC Drug Information

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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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