Data updated: Mar 10, 2026
SYLATRON
PEGINTERFERON ALFA-2B
Approved 2001-01-19
8
Indications
--
Phase 3 Trials
3
Priority Reviews
25
Years on Market
Details
- Status
- Prescription
- First Approved
- 2001-01-19
- Routes
- N/A
- Dosage Forms
- VIAL
SYLATRON Approval History
Loading approval history...
What SYLATRON Treats
8 FDA approvalsOriginally approved for its first indication in 2001 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Jan 2001)Label Letter
- • Approved indication (Aug 2001) PriorityLabel Letter
- • Approved indication (Mar 2008)
- • Approved indication (Dec 2008) PriorityLabel Letter
- • Approved indication (Mar 2009)Label Letter
- • Approved indication (May 2009)Label Letter
- • Approved indication (Mar 2011) PriorityLabel Letter
- • Approved indication (Dec 2013)Label Letter
🔬
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.
SYLATRON 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.