GVOKE HYPOPEN
Details
- Status
- Prescription
- First Approved
- 2019-09-10
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
GVOKE HYPOPEN Approval History
What GVOKE HYPOPEN Treats
1 indicationsGVOKE HYPOPEN is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoglycemia
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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.
GVOKE HYPOPEN FDA Label Details
ProIndications & Usage
FDA Label (PDF)Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: • for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. • as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. 1.1 Severe Hypoglycemia Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. 1.2 Diagnostic Aid Glucagon for Injection is indicated as a diagnostic aid for use during radiologic exami...
GVOKE HYPOPEN Patents & Exclusivity
Patents (18 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.