Lumiracoxib

Overview

Lumiracoxib is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID). On August 11, 2007, Australia's Therapeutic Goods Administration (TGA, the Australian equivalent of the FDA) cancelled the registration of lumiracoxib in Australia due to concerns that it may cause liver failure. New Zealand and Canada have also followed suit in recalling the drug.

Indication

For the acute and chronic treatment of the signs and symptoms of osteoarthritis of the knee in adults.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia	2011/11/29	NCT01481610	Phase 2	Terminated	Hospital Central Sur de Pemex
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)	2007/05/21	NCT00476034	Phase 3	Completed	Novartis
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)	2007/05/21	NCT00475800	Phase 3	Completed	Novartis
Effects of Lumiracoxib and Ibuprofen on Blood Pressure and Urinary Eicosanoid Excretion in Osteoarthritis Patients With Controlled Hypertension	2007/01/09	NCT00419796	Phase 4	Completed	Novartis
Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).	2006/08/22	NCT00366938	Phase 3	Completed	Novartis
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)	2006/08/22	NCT00367315	Phase 3	Completed	Novartis
Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel	2006/07/10	NCT00350155	Phase 4	Completed	Novartis
Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib	2006/07/04	NCT00348491	Phase 4	Completed	Novartis Pharmaceuticals
Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery	2006/06/05	NCT00333567	Phase 4	Completed	Novartis
Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension	2005/12/20	NCT00267176	Phase 4	Completed	Novartis Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
No Health Canada approvals found for this drug.

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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