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As of Nov 13, 2026, BLA 761377 (Eydenzelt), held by Celltrion Inc, was first approved by FDA on Oct 2, 2025, with 1 approved supplement and 2 published complete response letters.
First approved: Oct 2, 2025
Review: Standard
Supplements approved: 1
Complete response letters: 2
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 2 submissions below
Date
Submission
Status
Documents
Oct 2, 2025
Original applicationNew dosage form · Standard review
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
