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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  isatuximab-irfc
Trade Name:  Sarclisa
Date Designated:  05/22/2014
Orphan Designation:  Treatment of multiple myeloma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  03/31/2021 
Approved Labeled Indication:  in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
Exclusivity End Date:    03/31/2028 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 prior line of therapy, and for treatment of adult patients with relapsed or refractory multiple myeloma who have received 2 to 3 prior therapies excluding patients covered by the indication approved on March 2, 2020
Sanofi U.S. Services, Inc.
50 Binney St.
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  isatuximab
Trade Name:  Sarclisa
Date Designated:  05/22/2014
Orphan Designation:  Treatment of multiple myeloma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  03/02/2020 
Approved Labeled Indication:  SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Exclusivity End Date:    03/02/2027 
Exclusivity Protected Indication* :  Indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Sanofi U.S. Services, Inc.
50 Binney St.
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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