NORVASC (amlodipine besylate) · Viatris
Norvasc is a calcium channel blocker indicated for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events, specifically strokes and myocardial infarctions. It is also indicated for the symptomatic treatment of coronary artery disease, including chronic stable angina and vasospastic (Prinzmetal’s) angina, as well as for reducing the risk of hospitalization for angina in patients with angiographically documented CAD without heart failure or an ejection fraction < 40%.
How NORVASC Works
Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of extracellular calcium ions into vascular smooth muscle and cardiac muscle cells. It acts selectively on vascular smooth muscle, causing peripheral arterial vasodilation. This reduces total peripheral resistance and systemic blood pressure. In patients with angina, amlodipine decreases the myocardial oxygen demand by reducing afterload and prevents coronary artery constriction (vasospasm), thereby improving myocardial oxygen supply.
Details
- Status
- Prescription
- First Approved
- 1992-07-31
- Routes
- ORAL
- Dosage Forms
- TABLET
NORVASC Approval History
What NORVASC Treats
4 indicationsNORVASC is approved for 4 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Chronic Stable Angina
- Vasospastic Angina
- Coronary Artery Disease
NORVASC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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 NORVASC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NORVASC treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04434664 BLOCK HFpEF results posted | 833517 | Ph 4 | completed | BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF |
| NCT04974138 CSPPT2-CC/CT | CSPPT2-CC/CT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT) |
| NCT04974151 CSPPT2-TT | CSPPT2-TT_2020 | Ph 4 | recruiting | China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype |
| NCT05275907 | STU00215781 1R56HL155093-01 | Ph 4 | withdrawn | Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN) |
| NCT02940548 NARRAS | 2016PHB013-02 | Ph 4 | terminated | Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness |
| NCT01302691 results posted | 0954E-357 | Ph 3 | completed | MK-0954E Study in Participants With Hypertension (MK-0954E-357) |
| NCT02353806 results posted | 042014-059 UL1TR001105 | Ph 4 | completed | Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation |
| NCT01556997 PATH results posted | X985400 | Ph 3 | completed | Perindopril Amlodipine for the Treatment of Hypertension |
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.
NORVASC FDA Label Details
Indications & Usage
FDA Label (PDF)NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension o NORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • Coronary Artery Disease o Chronic Stable Angina o Vasospastic Angina (Prinzmetal’s or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.