AREDIA (pamidronate disodium) · Novartis
AREDIA is FDA-approved to treat 4 conditions (same as PAMIDRONATE DISODIUM).
Details
- Status
- Discontinued
- First Approved
- 1991-10-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AREDIA Approval History
What AREDIA Treats
4 indicationsAREDIA is approved for 4 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypercalcemia of Malignancy
- Paget's Disease of Bone
- Breast Cancer
- Multiple Myeloma
Same approved indications as PAMIDRONATE DISODIUM (same active ingredient).
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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
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.
AREDIA FDA Label Details
Indications & Usage
FDA Label (PDF)AREDIA is FDA-approved to treat 4 conditions — same approved indications as PAMIDRONATE DISODIUM.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.