FESOTERODINE FUMARATE · ZYDUS PHARMS
Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Pediatric use information is approved for Pfizer Inc.’s TOVIAZ (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Details
- Status
- Prescription
- First Approved
- 2008-10-31
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
FESOTERODINE FUMARATE Approval History
What FESOTERODINE FUMARATE Treats
1 indicationsFESOTERODINE FUMARATE is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
FESOTERODINE FUMARATE 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.
Drugs Similar to FESOTERODINE FUMARATE
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01786967 URGE results posted | 13-2066 1R03AG042335-01, Pro00036147 | Ph 3 | completed | Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE) |
| NCT01566760 | A0221069 | Ph 1 | completed | A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers |
| NCT01605617 results posted | 11-004589 | Ph 4 | terminated | Trial of Percutaneous Tibial Nerve Stimulation (PTNS) Versus PTNS and Fesoterodine Fumarate |
| NCT00798434 SOFIA results posted | A0221045 | Ph 4 | completed | A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder. |
| NCT00832650 results posted | A0221057 | Ph 1 | terminated | Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit |
| NCT00658684 results posted | A0221006 A0221006 | Ph 3 | completed | Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder. |
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.
FESOTERODINE FUMARATE FDA Label Details
Indications & Usage
Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Pediatric use information is approved for Pfizer Inc.’s TOVIAZ ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not ...
Looking for the branded version?
TOVIAZ
Full clinical data, patents, trials, and competitive landscape for fesoterodine fumarate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.