For an infliximab product administered intravenously. BLA 761358, held by Celltrion. Infliximab-Dyyb.
As of Nov 13, 2026, BLA 761358 (Zymfentra), held by Celltrion, was first approved by FDA on Oct 20, 2023, with 1 approved supplement and 0 published complete response letters.
ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn’s disease following with an infliximab products administered intraneously.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2023 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zymfentra120MG/ML · injectable;injection | Infliximab-Dyyb | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2024 | Supplement 1Manufacturing | Approved | |
| Oct 20, 2023 | Original applicationNew dosage form · 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
