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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant human lysosomal acid lipase or cholesteryl ester hydrolase
Date Designated: 07/14/2005
Orphan Designation: Treatment of lipase deficiencies, including Wolman Disease and cholesteryl ester storage disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lysosomal Acid Lipase, LLC
Subsidiary of Kentucky BioProcessing, LLC
3700 Airpark Drive
Owensboro, Kentucky 42301
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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