BAFIERTAM
Details
- Status
- Prescription
- First Approved
- 2020-04-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
BAFIERTAM Approval History
What BAFIERTAM Treats
1 indicationsBAFIERTAM is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
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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.
BAFIERTAM FDA Label Details
ProIndications & Usage
FDA Label (PDF)BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
BAFIERTAM Patents & Exclusivity
Patents (21 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.