Overview
A cyclooxygenase inhibiting, non-steroidal anti-inflammatory agent (NSAID) that is well established in treating rheumatoid arthritis and osteoarthritis and used for musculoskeletal disorders, dysmenorrhea, and postoperative pain. Its long half-life enables it to be administered once daily.
Indication
For treatment of osteoarthritis and rheumatoid arthritis.
Associated Conditions
- Ankylosing Spondylitis (AS)
- Osteoarthritis (OA)
- Rheumatoid Arthritis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/24 | Not Applicable | Completed | Federal Teaching Hospital Abakaliki | ||
2024/12/11 | Phase 3 | Not yet recruiting | |||
2024/05/08 | Phase 3 | Recruiting | Riadh Boukef | ||
2023/02/10 | Phase 2 | Recruiting | |||
2022/08/05 | Phase 4 | Completed | Farjad Zafar | ||
2021/11/03 | Phase 1 | Completed | Nanoform Finland Plc | ||
2019/10/11 | Phase 2 | Completed | |||
2019/08/20 | Early Phase 1 | Completed | |||
2019/06/26 | Not Applicable | UNKNOWN | |||
2018/11/19 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Vensun Pharmaceuticals, Inc. | 42543-114 | ORAL | 10 mg in 1 1 | 3/2/2018 | |
| Teva Pharmaceuticals USA, Inc. | 0093-0756 | ORAL | 10 mg in 1 1 | 2/14/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-210 | ORAL | 10 mg in 1 1 | 2/13/2023 | |
| DIRECT RX | 61919-188 | ORAL | 20 mg in 1 1 | 1/21/2020 | |
| Zydus Lifesciences Limited | 70771-1429 | ORAL | 10 mg in 1 1 | 10/4/2023 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-256 | ORAL | 20 mg in 1 1 | 4/19/2023 | |
| Proficient Rx LP | 71205-032 | ORAL | 20 mg in 1 1 | 12/1/2018 | |
| Quality Care Products, LLC | 55700-697 | ORAL | 20 mg in 1 1 | 11/21/2018 | |
| Bryant Ranch Prepack | 71335-9622 | ORAL | 20 mg in 1 1 | 12/6/2022 | |
| Greenstone LLC | 59762-0140 | ORAL | 10 mg in 1 1 | 2/2/2023 |
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 |
|---|---|---|---|---|---|
| ROSIDEN INJECTION 20 mg/ml | SIN06575P | INJECTION | 20 mg/ml | 9/16/1991 | |
| ROSIDEN CAPSULE 20 mg | SIN06131P | CAPSULE | 20 mg | 5/22/1991 | |
| ROSIDEN GEL | SIN05100P | GEL | 5 mg/g | 10/3/1990 | |
| APO-PIROXICAM CAPSULE 10 mg | SIN05491P | CAPSULE | 10 mg | 2/8/1991 | |
| ROXIFEN GEL 500 mg/100 g | SIN10968P | GEL | 500 mg/100 g | 6/5/1999 | |
| APO-PIROXICAM CAPSULE 20 mg | SIN05893P | CAPSULE | 20 mg | 5/22/1991 | |
| BREXIN TABLET 20 mg | SIN07791P | TABLET | 20 mg | 7/15/1994 |
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 |
|---|---|---|---|---|---|
| PIROCAM INJ 20MG/ML | N/A | N/A | N/A | 7/20/1996 | |
| PIRUX CAPSULES 10MG | N/A | N/A | N/A | 7/17/2013 | |
| FIP TORICAM GEL 1% | N/A | N/A | N/A | 7/23/2007 | |
| FEDCOVIT CAP 10MG | N/A | N/A | N/A | 5/3/1995 | |
| CP-PIROX 20 CAP 20MG | N/A | N/A | N/A | 9/29/1999 | |
| REUMOXICAN CREAM 1%W/W | N/A | wings pharmaceutical ltd | N/A | N/A | 7/4/2016 |
| PIROCAM CAP 10MG | N/A | N/A | N/A | 11/12/1982 | |
| PFIDENE TAB 20MG | N/A | N/A | N/A | 9/26/2001 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MOBILIS D-10 piroxicam 10mg dispersible tablet blister pack | 53282 | Medicine | A | 8/8/1995 | |
| APO-PIROXICAM piroxicam 20 mg capsule blister pack | 75043 | Medicine | A | 8/30/2000 | |
| GENRX PIROXICAM DISPERSIBLE piroxicam 20mg tablet blister pack | 78364 | Medicine | A | 7/3/2001 | |
| PIROXICAM-DWRN piroxicam 10mg capsule blister pack | 422371 | Medicine | A | 12/11/2023 | |
| APO-PIROXICAM piroxicam 10mg capsule blister pack | 75039 | Medicine | A | 8/30/2000 | |
| PIROXICAM-DWRN piroxicam 20 mg capsule blister pack | 422372 | Medicine | A | 12/11/2023 | |
| PIROXICAM-RJIC piroxicam 20 mg capsule blister pack | 422391 | Medicine | A | 12/11/2023 | |
| PIROXICAM-RJIC piroxicam 10mg capsule blister pack | 422390 | Medicine | A | 12/11/2023 | |
| FELDENE-D piroxicam 20mg tablet | 37312 | Medicine | A | 11/24/1992 | |
| MOBILIS 10 piroxicam 10mg capsule bottle | 52201 | Medicine | A | 5/2/1995 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| NU-PIROX CAP 10MG | nu-pharm inc | 00865761 | Capsule - Oral | 10 MG | 12/31/1990 |
| RHO-PIROXICAM - CAP 20MG | rhodiapharm inc | 02144220 | Capsule - Oral | 20 MG / CAP | 12/31/1995 |
| DOM-PIROXICAM | dominion pharmacal | 02239536 | Capsule - Oral | 20 MG | 10/25/1999 |
| ALTI-PIROXICAM-CAP 10MG | altimed pharma inc. | 02139952 | Capsule - Oral | 10 MG / CAP | 9/24/1997 |
| PENTA-PIROXICAM CAPSULES | pentapharm ltd. | 02232550 | Capsule - Oral | 20 MG / CAP | N/A |
| GEN-PIROXICAM - CAP 20MG | genpharm ulc | 02171821 | Capsule - Oral | 20 MG | 12/31/1995 |
| TEVA-PIROXICAM | teva canada limited | 00695718 | Capsule - Oral | 10 MG | 12/31/1986 |
| FELDENE CAP 20MG | 00525618 | Capsule - Oral | 20 MG / CAP | 12/31/1981 | |
| APO PIROXICAM CAP 10MG | 00642886 | Capsule - Oral | 10 MG | 12/31/1986 | |
| FELDENE SUP 10MG | 00632708 | Suppository - Rectal | 10 MG / SUP | 12/31/1986 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SASULEN 5 MG/G GEL | Laboratorios Veris S.A. | 58708 | GEL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PIROXICAM CINFA 20 mg COMPRIMIDOS DISPERSABLES EFG | Laboratorios Cinfa S.A. | 62418 | COMPRIMIDO DISPERSABLE | Diagnóstico Hospitalario | Commercialized |
| FELDENE 20 MG/ML SOLUCION INYECTABLE | Pfizer S.L. | 58085 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Not Commercialized |
| IMPRONTAL 5 mg/g CREMA | Meda Pharma S.L. | 58198 | CREMA | Sin Receta | Not Commercialized |
| FELDENE 20 MG CAPSULAS DURAS | Pfizer S.L. | 55806 | CÁPSULA DURA | Diagnóstico Hospitalario | Commercialized |
| SALVACAM 5mg/g GEL | Laboratorios Salvat S.A. | 58986 | GEL | Sin Receta | Commercialized |
| FELDENE FLAS 20 mg LIOFILIZADO ORAL | Pfizer S.L. | 60070 | LIOFILIZADO ORAL | Diagnóstico Hospitalario | Commercialized |
| FELDENE 10 MG CAPSULAS DURAS | Pfizer S.L. | 55382 | CÁPSULA DURA | Diagnóstico Hospitalario | Not Commercialized |
| FELDEGEL 5 mg/g GEL | Pfizer S.L. | 57797 | GEL | Medicamento Sujeto A Prescripción Médica | Not 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. | |||||
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