LOPID
Details
- Status
- Prescription
- First Approved
- 1981-12-21
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
LOPID Approval History
What LOPID Treats
2 indicationsLOPID is approved for 2 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertriglyceridemia
- Pancreatitis
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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.
LOPID FDA Label Details
ProIndications & Usage
FDA Label (PDF)LOPID (gemfibrozil tablets, USP) is indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to prese...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.