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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:  12/14/2009
Orphan Designation:  Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/27/2019 
Approved Labeled Indication:  CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
Exclusivity End Date:    09/27/2026 
Exclusivity Protected Indication* :  For the treatment of X-linked hypophosphatemia (XLH) in pediatric patients 6 months of age to less than 1 year of age
Kyowa Kirin, Inc.
135 US Highway 202/206
Suite 6
Bedminster, New Jersey 07921
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  burosumab-twza
Trade Name:  Crysvita
Date Designated:  12/14/2009
Orphan Designation:  Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  04/17/2018 
Approved Labeled Indication:  CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Exclusivity End Date:    04/17/2025 
Exclusivity Protected Indication* :  CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Kyowa Kirin, Inc.
135 US Highway 202/206
Suite 6
Bedminster, New Jersey 07921
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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