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 |
| Sponsor: |
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 |
| Sponsor: |
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. |
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