VASOTEC
Details
- Status
- Prescription
- First Approved
- 1985-12-24
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
VASOTEC Approval History
What VASOTEC Treats
3 indicationsVASOTEC is approved for 3 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Heart Failure
- Left Ventricular Dysfunction
VASOTEC Boxed Warning
FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASOTEC ® as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS, Fetal Toxicity )....
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASOTEC ® as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS, Fetal Toxicity ).
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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.
VASOTEC FDA Label Details
ProIndications & Usage
FDA Label (PDF)Hypertension VASOTEC is indicated for the treatment of hypertension. VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive. Heart Failure VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY , Heart Failure , Mortality Trials for ...
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASOTEC ® as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS, Fetal Toxicity )....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.