FDA BLA · BLA761136

REBLOZYL

luspatercept

Sponsor: CELGENE CORP

What this page does not claim

A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.

APPLICATION
BLA761136
TYPE
BLA
ORIGINAL APPROVAL
2019-11-08
LATEST ACTION
2026-10-20
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

REBLOZYLPrescription
LUSPATERCEPT-AAMT 75MG/VIAL · POWDER · SUBCUTANEOUS
REBLOZYLPrescription
LUSPATERCEPT-AAMT 25MG/VIAL · POWDER · SUBCUTANEOUS

Approval history

2026-10-20Labeling · Supplement 17 · standard — Letter ↗AP
2026-02-27Labeling · Supplement 15 · standard — Letter ↗AP
2024-05-16Labeling · Supplement 10 · standard — Label ↗AP
2023-08-28Efficacy · Supplement 9 · priority — Label ↗AP
2022-07-08Labeling · Supplement 6 · standard — Letter ↗AP
2020-04-03Efficacy · Original · standard — Label ↗AP
2019-11-08Type 1 - New Molecular Entity · Original · priority — Label ↗AP