Data updated: Mar 10, 2026
FESOTERODINE FUMARATE
FESOTERODINE FUMARATE
Approved 2015-12-10
7
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-12-10
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
CHARTWELL RX HETERO LABS LTD V Dr. Reddy's Aurobindo Pharma ANI PHARMS ALKEM LABS LTD ZYDUS PHARMS AMNEAL PHARMS NY Teva ALEMBIC ACCORD HLTHCARE Novartis Sun Pharma
Active Ingredient: FESOTERODINE FUMARATE
Website: ↗
FESOTERODINE FUMARATE Approval History
Loading approval history...
What FESOTERODINE FUMARATE Treats
7 FDA approvalsOriginally approved for its first indication in 2015 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Dec 2015)
- • Approved indication (Feb 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Aug 2019)
- • Approved indication (Jan 2023)
- • Approved indication (Jan 2023)
- • Approved indication (Jan 2024)
🔬
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.
FESOTERODINE FUMARATE 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.