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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: luspatercept-aamt
Trade Name: Reblozyl
Date Designated: 03/18/2013
Orphan Designation: Treatment of myelodysplastic syndrome
Orphan Designation Status: Designated/Approved
Celgene Corporation, a Bristol-Myers Squibb Company
86 Morris Avenue
Summit, New Jersey 07901
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: luspatercept-aamt
Trade Name: Reblozyl
Marketing Approval Date: 04/03/2020
Approved Labeled Indication: REBLOZYL is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Exclusivity End Date: 04/03/2027 
Exclusivity Protected Indication* :  For the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS)
2 Generic Name: luspatercept-aamt
Trade Name: Reblozyl
Marketing Approval Date: 08/28/2023
Approved Labeled Indication: treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naive) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions
Exclusivity End Date: 08/28/2030 
Exclusivity Protected Indication* :  treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naive) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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