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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  adeno-associated virus serotype 5 (AAV5) vector containing the hSERPING cDNA sequence encoding human C1-esterase inhibitor (C1-INH)
Date Designated:  12/20/2021
Orphan Designation:  Treatment of hereditary angioedema
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
BioMarin Pharmaceutical, Inc.
105 Digital Drive
Novato, California 94949
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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