CARDURA (doxazosin mesylate) · Viatris
Cardura helps patients with high blood pressure and those experiencing the symptoms of an enlarged prostate, also known as benign prostatic hyperplasia. It is used to lower blood pressure, which helps reduce the risk of serious cardiovascular events like strokes and heart attacks. For men with prostate issues, it helps manage urinary difficulties such as frequency, a weak stream, and the feeling of incomplete bladder emptying.
How CARDURA Works
This drug works by selectively blocking alpha 1 adrenergic receptors, which are found in high density in the prostate and bladder neck. By blocking these receptors, the medication relaxes smooth muscle tone to decrease urethral resistance and improve urine flow. In the circulatory system, this same blockade lowers blood pressure by decreasing systemic vascular resistance.
Details
- Status
- Prescription
- First Approved
- 1990-11-02
- Routes
- ORAL
- Dosage Forms
- TABLET
CARDURA Approval History
What CARDURA Treats
2 indicationsCARDURA is approved for 2 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.
CARDURA 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 CARDURA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CARDURA treats. First-in-class if their pivotal trials read out positive.
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Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
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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.
CARDURA FDA Label Details
Indications & Usage
FDA Label (PDF)CARDURA is an alpha 1 adrenergic antagonist indicated for: • Signs and symptoms of Benign Prostatic Hyperplasia (BPH) • Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) CARDURA is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension CARDURA 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologi...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.