VASERETIC
Details
- Status
- Prescription
- First Approved
- 1986-10-31
- Routes
- ORAL
- Dosage Forms
- TABLET
VASERETIC Approval History
What VASERETIC Treats
3 indicationsVASERETIC is approved for 3 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Renal Impairment
- Angioedema
VASERETIC Boxed Warning
FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASERETIC ® 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 VASERETIC ® 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.
VASERETIC FDA Label Details
ProIndications & Usage
FDA Label (PDF)VASERETIC is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using VASERETIC, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril does not have a similar risk (see WARNINGS ). In considering use of VASERETIC, it should be noted that black patients receiving ACE inhibitors ha...
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASERETIC ® 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.