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FDA BLA · BLA761136

REBLOZYL

luspatercept

Sponsor: CELGENE CORP

APPLICATION
BLA761136
TYPE
BLA
ORIGINAL APPROVAL
2019-11-08
LATEST ACTION
2026-02-27
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

2026-02-27Labeling · 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
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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