BETASERON
BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis in adult patients. The medication is used to manage a spectrum of the disease, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It serves as a therapeutic option specifically for adults experiencing these relapsing forms of the condition.
How BETASERON Works
The precise mechanism of action of BETASERON in patients with multiple sclerosis is currently unknown. While the drug is classified as an interferon beta-1b, the specific biological targets or pathways it interacts with to produce a therapeutic effect have not been established. Consequently, the exact process by which it impacts the progression or symptoms of multiple sclerosis remains unidentified.
Details
- Status
- Prescription
- First Approved
- 1993-07-23
- Routes
- SUBCUTANEOUS
- Dosage Forms
- VIAL
BETASERON Approval History
What BETASERON Treats
1 indicationsBETASERON is approved for 1 conditions since its original approval in 1993. 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.
BETASERON FDA Label Details
ProIndications & Usage
FDA Label (PDF)BETASERON 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. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.