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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lanadelumab-flyo
Trade Name: Takhzyro
Date Designated: 11/26/2013
Orphan Designation: Treatment of angioedema
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: lanadelumab-flyo
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
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
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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