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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: C1 esterase inhibitor (human)
Date Designated: 08/21/1996
Orphan Designation: Treatment and prevention of angioedema caused by C1-esterase inhibitor deficiency.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, California 90032
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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