CATAFLAM (diclofenac potassium)
CATAFLAM is indicated for the treatment of Dysmenorrhea; Pain; Osteoarthritis; Rheumatoid Arthritis.
Details
- Status
- Discontinued
- First Approved
- 1993-11-24
- Routes
- ORAL
- Dosage Forms
- TABLET
CATAFLAM Approval History
What CATAFLAM Treats
4 indicationsCATAFLAM is approved for 4 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dysmenorrhea
- Pain
- Osteoarthritis
- Rheumatoid Arthritis
CATAFLAM Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS ). Diclofenac potassium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS ,...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS ). Diclofenac potassium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS , WARNINGS ). Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see WARNINGS ).
CATAFLAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CATAFLAM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CATAFLAM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CATAFLAM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06731270 | STUDY00006572 NCI-2024-07760, STUDY00006572 | Ph 2 | recruiting | Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy |
| NCT02255045 | AVM002 | Ph 2, Ph 3 | completed | Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea |
| NCT02714699 | HB-OH | Ph 2, Ph 3 | completed | Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy |
| NCT02476422 results posted | CCAT458M2402 | Ph 3 | completed | A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain |
| NCT01019980 results posted | CVOL458AVE02 | Ph 4 | terminated | Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections |
| NCT01257126 | CCAT458CMX01 | Ph 4 | withdrawn | Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CATAFLAM FDA Label Details
Indications & Usage
FDA Label (PDF)CATAFLAM is indicated for the treatment of Dysmenorrhea; Pain; Osteoarthritis; Rheumatoid Arthritis.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.