BONIVA (ibandronate sodium) · Roche
BONIVA is FDA-approved to treat 1 condition (same as IBANDRONATE SODIUM).
Details
- Status
- Discontinued
- First Approved
- 2003-05-16
- Routes
- INTRAVENOUS, ORAL
- Dosage Forms
- INJECTABLE, TABLET
BONIVA Approval History
What BONIVA Treats
1 indicationsBONIVA is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as IBANDRONATE SODIUM (same active ingredient).
Roche'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 |
|---|---|---|---|---|
| NCT01627886 | BA0859144-01 | Ph 1 | completed | Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition |
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.
BONIVA FDA Label Details
Indications & Usage
FDA Label (PDF)BONIVA is FDA-approved to treat 1 condition — same approved indications as IBANDRONATE SODIUM.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.