Search Orphan Drug Designations and Approvals
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Generic Name: | lanadelumab-flyo | ||||||||||||||||
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Trade Name: | Takhzyro | ||||||||||||||||
Date Designated: | 11/26/2013 | ||||||||||||||||
Orphan Designation: | Treatment of angioedema | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Takeda Pharmaceuticals USA, Inc. 500 Kendall Street Cambridge, Massachusetts 02142 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: | lanadelumab-flyo |
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Trade Name: | Takhzyro | |
Marketing Approval Date: | 08/23/2018 | |
Approved Labeled Indication: | Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older | |
Exclusivity End Date: | 08/23/2025 | |
Exclusivity Protected Indication* : | Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older | |
2 | Generic Name: | lanadelumab-flyo |
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Trade Name: | Takhzyro | |
Marketing Approval Date: | 02/03/2023 | |
Approved Labeled Indication: | prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older | |
Exclusivity End Date: | 02/03/2030 | |
Exclusivity Protected Indication* : | prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged 2 years to less than 12 years | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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