MIOSTAT
Details
- Status
- Prescription
- First Approved
- 1972-09-28
- Routes
- INTRAOCULAR
- Dosage Forms
- SOLUTION
MIOSTAT Approval History
What MIOSTAT Treats
2 indicationsMIOSTAT is approved for 2 conditions since its original approval in 1972. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Miosis
- Intraocular Pressure Elevation
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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.
MIOSTAT FDA Label Details
ProIndications & Usage
FDA Label (PDF): Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT* (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP elevation in the first 24 hours after cataract surgery.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.