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As of Nov 13, 2026, BLA 761082 (Releuko), held by Kashiv Biosciences LLC, was first approved by FDA on Feb 25, 2022, with 4 approved supplements and 4 published complete response letters.
First approved: Feb 25, 2022
Review: Standard
Supplements approved: 4
Complete response letters: 4
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 5 submissions below
Date
Submission
Status
Documents
Feb 25, 2022
Original applicationNew formulation or manufacturer · 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
