VALSARTAN AND HYDROCHLOROTHIAZIDE
Details
- Status
- Prescription
- First Approved
- 2012-09-21
- Routes
- ORAL
- Dosage Forms
- TABLET
VALSARTAN AND HYDROCHLOROTHIAZIDE Approval History
What VALSARTAN AND HYDROCHLOROTHIAZIDE Treats
6 FDA approvalsOriginally approved for its first indication in 2012 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals)- • Approved indication (Sep 2012)Letter
- • Approved indication (Mar 2013)
- • Approved indication (Apr 2013)
- • Approved indication (Feb 2016)
- • Approved indication (Mar 2019)
- • Approved indication (Aug 2023)
VALSARTAN AND HYDROCHLOROTHIAZIDE Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue valsartan and hydrochlorothiazide tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue valsartan and hydrochlorothiazide tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause in...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue valsartan and hydrochlorothiazide tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue valsartan and hydrochlorothiazide tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
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.
VALSARTAN AND HYDROCHLOROTHIAZIDE FDA Label Details
ProIndications & Usage
Valsartan and hydrochlorothiazide tablets are 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 pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets....
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue valsartan and hydrochlorothiazide tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing informat...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.