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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: burosumab-twza
Trade Name: Crysvita
Date Designated: 06/15/2017
Orphan Designation: Treatment of tumor-induced osteomalacia (TIO) syndrome
Orphan Designation Status: Designated/Approved
Kyowa Kirin, Inc.
135 US Highway 202 206
Suite 6
Bedminster Township, New Jersey 07921
United States

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

Marketing approved:

1 Generic Name: burosumab-twza
Trade Name: Crysvita
Marketing Approval Date: 06/18/2020
Approved Labeled Indication: Crysvita (burosumab-twza) is indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.
Exclusivity End Date: 06/18/2027 
Exclusivity Protected Indication* :  For the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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