Reblozyl

BLA 761136, held by Celgene Corp. Luspatercept-Aamt.

As of Nov 14, 2026, BLA 761136 (Reblozyl), held by Celgene Corp, was first approved by FDA on Apr 3, 2020, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 3, 2020
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Aug 28, 2023	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Apr 3, 2020	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 8, 2019	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


Reblozyl25MG/VIAL · powder;subcutaneous	Luspatercept-Aamt	Rx
Reblozyl75MG/VIAL · powder;subcutaneous	Luspatercept-Aamt	Rx

All 7 submissions, including labeling and manufacturing supplements


Oct 20, 2026	Supplement 17Labeling · Standard review	Approved	Label Letter
Feb 27, 2026	Supplement 15Labeling · Standard review	Approved	Label Letter
May 16, 2024	Supplement 10Labeling · Standard review	Approved	Letter Label
Aug 28, 2023	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 8, 2022	Supplement 6Labeling · Standard review	Approved	Letter Label
Apr 3, 2020	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 8, 2019	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: BLA 761136
Drugs@FDA: Overview at FDA
Company: Celgene Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters