TRANDOLAPRIL · WATSON LABS INC
Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (see CLINICAL PHARMACOLOGY -Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for...
Details
- Status
- Prescription
- First Approved
- 1996-04-26
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TRANDOLAPRIL Approval History
What TRANDOLAPRIL Treats
4 indicationsTRANDOLAPRIL is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
- Heart Failure
- Left Ventricular Dysfunction
- Myocardial Infarction
TRANDOLAPRIL Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue trandolapril 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 When pregnancy is detected, discontinue trandolapril 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 .)
TRANDOLAPRIL 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 TRANDOLAPRIL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRANDOLAPRIL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TRANDOLAPRIL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
TRANDOLAPRIL FDA Label Details
Indications & Usage
Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of tr...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue trandolapril 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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MAVIK
Full clinical data, patents, trials, and competitive landscape for trandolapril.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.