FELODIPINE · GLENMARK PHARMS LTD
Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine.
Details
- Status
- Prescription
- First Approved
- 1991-07-25
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
FELODIPINE Approval History
What FELODIPINE Treats
1 indicationsFELODIPINE is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
FELODIPINE 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 FELODIPINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FELODIPINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FELODIPINE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02232269 | R-11-655 NA-7122 | Ph 1 | completed | Coffee Interaction With the Antihypertensive Drug Felodipine |
| NCT02744872 CARCATS | 2008-004771-22 | Ph 4 | completed | Copenhagen Acute Renal Complications After Transplantations Study Group |
| NCT00905333 | D2452L00021 IMPACT 15381 | Ph 1 | completed | Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal |
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.
FELODIPINE FDA Label Details
Indications & Usage
Felodipine extended-release tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise...
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Full clinical data, patents, trials, and competitive landscape for felodipine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.