Data updated: May 26, 2026
IXIFI (infliximab-qbtx)
Immunology
Approved 2017-12-13
2
Indications
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-12-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
IXIFI Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2017 to 2025 · 1 indication expansions
What IXIFI Treats
2 FDA approvalsOriginally approved for its first indication in 2017 . Covers 2 distinct patient populations.
- Other (2)
IXIFI is a lower-cost alternative to Remicade with no clinically meaningful differences. Requires prescriber approval to substitute.
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Pro Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
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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.
IXIFI FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.