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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ecallantide
Trade Name: Kalbitor
Date Designated: 02/04/2003
Orphan Designation: Treatment of angioedema
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals U.S.A., 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: ecallantide
Trade Name: Kalbitor
Marketing Approval Date: 12/01/2009
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema in patients 16 years of age and older
Exclusivity End Date: 12/01/2016 
Exclusivity Protected Indication* :  
2 Generic Name: ecallantide
Trade Name: Kalbitor
Marketing Approval Date: 03/28/2014
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older
Exclusivity End Date: 03/28/2021 
Exclusivity Protected Indication* :  Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 through 15 years of age.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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