PAMIDRONATE DISODIUM · AREVA PHARMS
Hypercalcemia of Malignancy Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium.
Details
- Status
- Prescription
- First Approved
- 1991-10-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
PAMIDRONATE DISODIUM Approval History
What PAMIDRONATE DISODIUM Treats
4 indicationsPAMIDRONATE DISODIUM is approved for 4 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypercalcemia of Malignancy
- Paget's Disease of Bone
- Breast Cancer
- Multiple Myeloma
PAMIDRONATE DISODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PAMIDRONATE DISODIUM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PAMIDRONATE DISODIUM treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02544659 | PUMCH-SAPHO-01 | Ph 1 | completed | Efficacy of Bisphosphonates in Patients With Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) Syndrome |
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.
PAMIDRONATE DISODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)Hypercalcemia of Malignancy Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures ...
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AREDIA
Full clinical data, patents, trials, and competitive landscape for pamidronate disodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.