BLA 761072, held by Pfizer Inc. Infliximab-Qbtx.
As of Nov 13, 2026, BLA 761072 (Ixifi), held by Pfizer Inc, was first approved by FDA on Dec 13, 2017, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2020 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ixifi100MG/VIAL · injectable;injection | Infliximab-Qbtx | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2025 | Supplement 14Biosimilar | Approved | |
| Dec 26, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Jan 16, 2020 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
