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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ADAMTS13, recombinant-krhn
Trade Name: Adzynma
Date Designated: 07/29/2008
Orphan Designation: Treatment of thrombotic thrombocytopenic purpura including its congenital, acquired idiopathic, and secondary forms
Orphan Designation Status: Designated/Approved
Takeda Development Center Americas, Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
United States

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

Marketing approved:

1 Generic Name: ADAMTS13, recombinant-krhn
Trade Name: Adzynma
Marketing Approval Date: 11/09/2023
Approved Labeled Indication: prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP)
Exclusivity End Date: 11/09/2030 
Exclusivity Protected Indication* :  prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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