Data updated: Mar 10, 2026
ACTONEL
RISEDRONATE SODIUM
Approved 1998-03-27
8
Indications
--
Phase 3 Trials
2
Priority Reviews
27
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1998-03-27
- Routes
- ORAL
- Dosage Forms
- TABLET
ACTONEL Approval History
Loading approval history...
What ACTONEL Treats
8 FDA approvalsOriginally approved for its first indication in 1998 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Mar 1998)Letter
- • Approved indication (Apr 2000) PriorityLabel Letter
- • Approved indication (May 2002)Label Letter
- • Approved indication (Jan 2006)Label Letter
- • Approved indication (Aug 2006)Label Letter
- • Approved indication (Apr 2007)Label Letter
- • Approved indication (Apr 2008)Letter
- • Approved indication (Jul 2009) PriorityLabel Letter
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
ACTONEL FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.