PROGLYCEM
Details
- Status
- Prescription
- First Approved
- 1976-05-28
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, CAPSULE
PROGLYCEM Approval History
What PROGLYCEM Treats
9 indicationsPROGLYCEM is approved for 9 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoglycemia
- Hyperinsulinism
- Islet Cell Adenoma
- Islet Cell Carcinoma
- Extrapancreatic Malignancy
- Leucine Sensitivity
- Islet Cell Hyperplasia
- Nesidioblastosis
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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.
PROGLYCEM FDA Label Details
ProIndications & Usage
FDA Label (PDF)PROGLYCEM is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. PROGLYCEM may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists. PROGLYCEM should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.