Is Valdecoxib approved by the US FDA?

Drugs@FDA lists 1 application product line for Valdecoxib, including BEXTRA (Discontinued).

Is Valdecoxib authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Valdecoxib.

Active substance

Valdecoxib

US FDA 1
EMA 3

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BEXTRA	10MG; 20MG	tablet · oral	GD SEARLE	Discontinued	16 Nov 2001

EMA European Union — centrally authorised medicines

Bextra Pharmacia - Pfizer EEIG · Withdrawn · authorised 27 Mar 2003 · ATC M01AH03

Therapeutic indication (EMA)

Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risk (see sections 4.3, 4.4).

Valdyn Pharmacia Europe EEIG · Withdrawn · authorised 27 Mar 2003 · ATC M01AH03

Therapeutic indication (EMA)

Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.

Valdyn (previously Kudeq) Pfizer Limited · Withdrawn · authorised 27 Mar 2003 · ATC M01AH03

Therapeutic indication (EMA)

Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.Treatment of primary dysmenorrhoea.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.