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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sebelipase alfa
Trade Name: Kanuma
Date Designated: 07/01/2010
Orphan Designation: Treatment of lysosomal acid lipase deficiency
Orphan Designation Status: Designated/Approved
Alexion Pharmaceuticals
100 College Street
New Haven, Connecticut 06510
United States

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

Marketing approved:

1 Generic Name: sebelipase alfa
Trade Name: Kanuma
Marketing Approval Date: 12/08/2015
Approved Labeled Indication: Indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency
Exclusivity End Date: 12/08/2022 
Exclusivity Protected Indication* :  Indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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