CELECOXIB
Details
- Status
- Prescription
- First Approved
- 2014-05-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
CELECOXIB Approval History
What CELECOXIB Treats
26 FDA approvalsOriginally approved for its first indication in 2014 . Covers 26 distinct patient populations.
- Other (26)
Other
(26 approvals)- • Approved indication (May 2014)Letter
- • Approved indication (Oct 2014)Label Letter
- • Approved indication (Feb 2015)
- • Approved indication (Jun 2015)
- • Approved indication (Jun 2015)
- • Approved indication (Aug 2015)
- • Approved indication (Sep 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Feb 2016)Label Letter
- • Approved indication (Mar 2016)
- • Approved indication (Apr 2017)
- • Approved indication (Jan 2018)
- • Approved indication (Apr 2018)
- • Approved indication (May 2018)
- • Approved indication (Aug 2019)
- • Approved indication (Nov 2019)
- • Approved indication (Nov 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Mar 2020)
- • Approved indication (May 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Apr 2023)
- • Approved indication (Apr 2025) New
- • Approved indication (Jul 2025) New
CELECOXIB Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTRO-INTESTINAL 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 the treatment and may increase with duration of use [ see Warnings and Precautions (5.1) ]. Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraind...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTRO-INTESTINAL 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 the treatment and may increase with duration of use [ see Warnings and Precautions (5.1) ]. Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4) and Warnings and Precautions (5.1) ]. 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 c an 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 and Precautions (5.2) ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. 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 the treatment and may increase with duration of use. ( 5.1 ) Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) 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. ( 5.2 )
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.
CELECOXIB FDA Label Details
ProIndications & Usage
FDA Label (PDF)Celecoxib is indicated Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) Rheumatoid Arthritis (RA) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older Ankylosing Spondylitis (AS) Acute Pain (AP) Primary Dysmenorrhea (PD) 1.1 Osteoarthritis For the management of the signs and symptoms of OA [ see Clinical Studies ]. 1.2 Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see Clinical Studies ]. 1.3 Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical ...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTRO-INTESTINAL 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 occu...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.