KINEVAC
Details
- Status
- Prescription
- First Approved
- 1976-07-21
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
KINEVAC Approval History
What KINEVAC Treats
2 FDA approvalsOriginally approved for its first indication in 1976 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jul 1976) Priority
- • Approved indication (Aug 1986)
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.
KINEVAC FDA Label Details
ProIndications & Usage
FDA Label (PDF)Kinevac is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examinatio...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.