RISEDRONATE SODIUM
Risedronate sodium delayed-release tablets are bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use .
Details
- Status
- Prescription
- First Approved
- 2007-10-05
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE, TABLET
Companies
RISEDRONATE SODIUM Approval History
What RISEDRONATE SODIUM Treats
13 FDA approvalsOriginally approved for its first indication in 2007 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Oct 2007)Label Letter
- • Approved indication (Jun 2014)
- • Approved indication (Jun 2014)
- • Approved indication (May 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Oct 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Jun 2018)
- • Approved indication (Sep 2018)
- • Approved indication (Feb 2019)
- • Approved indication (May 2019)
- • Approved indication (Jul 2019)
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03208582 BAMES | SCH-2013 | Ph 2 | completed | Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta? |
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.
RISEDRONATE SODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)Risedronate sodium delayed-release tablets are bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use . 1.1 Postmenopausal Osteoporosis Risedronate sodium delayed-release tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.