R-GENE 10
Details
- Status
- Prescription
- First Approved
- 1973-02-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
R-GENE 10 Approval History
What R-GENE 10 Treats
6 indicationsR-GENE 10 is approved for 6 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Panhypopituitarism
- Pituitary Dwarfism
- Chromophobe Adenoma
- Craniopharyngioma
- Acromegaly
- Gigantism
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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.
R-GENE 10 FDA Label Details
ProIndications & Usage
FDA Label (PDF)R-Gene ® 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature. If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene ® 10 is advisable to confirm the negative r...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.