MEFENAMIC ACID
Details
- Status
- Prescription
- First Approved
- 2010-11-19
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MEFENAMIC ACID Approval History
What MEFENAMIC ACID Treats
5 FDA approvalsOriginally approved for its first indication in 2010 . Covers 5 distinct patient populations.
- Other (5)
Other
(5 approvals)- • Approved indication (Nov 2010)
- • Approved indication (Jul 2011)
- • Approved indication (Feb 2013)
- • Approved indication (Jun 2014)
- • Approved indication (Sep 2020)
MEFENAMIC ACID 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 ). Mefenamic acid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see Contraindications , Warnings ). G...
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 ). Mefenamic acid is 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 ).
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.
MEFENAMIC ACID FDA Label Details
ProIndications & Usage
Carefully consider the potential benefits and risks of mefenamic acid capsules and other treatment options before deciding to use mefenamic acid capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ; Gastrointestinal Bleeding, Ulceration, and Perforation ). Mefenamic acid capsules are indicated: For relief of mild to moderate pain in patients ≥14 years of age, when therapy will not exceed one week (7 days). For treatment of primary dysmenorrhea.
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.