Search Orphan Drug Designations and Approvals
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Generic Name: | burosumab-twza | ||||||||||||||||
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Trade Name: | Crysvita | ||||||||||||||||
Date Designated: | 06/15/2017 | ||||||||||||||||
Orphan Designation: | Treatment of tumor-induced osteomalacia (TIO) syndrome | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | burosumab-twza |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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