ROCALTROL
Details
- Status
- Prescription
- First Approved
- 1978-08-17
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SOLUTION
ROCALTROL Approval History
What ROCALTROL Treats
7 indicationsROCALTROL is approved for 7 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Hyperparathyroidism
- Metabolic Bone Disease
- Chronic Renal Failure
- Hypocalcemia
- Osteitis Fibrosa Cystica
- Hypoparathyroidism
- Pseudohypoparathyroidism
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Active Pipeline
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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.
ROCALTROL FDA Label Details
ProIndications & Usage
FDA Label (PDF)Predialysis Patients Calcitriol Oral Solution is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol Oral Solution is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.