METOLAZONE
Details
- Status
- Prescription
- First Approved
- 2003-12-19
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
METOLAZONE Approval History
What METOLAZONE Treats
6 indicationsMETOLAZONE is approved for 6 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Salt and Water Retention
- Edema
- Congestive Heart Failure
- Renal Disease
- Nephrotic Syndrome
- Hypertension
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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.
METOLAZONE FDA Label Details
ProIndications & Usage
Metolazone is indicated for the treatment of salt and water retention including: • edema accompanying congestive heart failure; • edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. Mykrox ® tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if Mykrox ® tablets are to be substituted...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.