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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mipomersen
Trade Name: KYNAMRO
Date Designated: 05/23/2006
Orphan Designation: Treatment of homozygous familial hypercholesterolemia
Orphan Designation Status: Designated/Approved
Kastle Therapeutics, LLC
181 West Madison Street
Suite 3745
Chicago, Illinois 60602
United States

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

Marketing approved:

1 Generic Name: mipomersen
Trade Name: KYNAMRO
Marketing Approval Date: 01/29/2013
Approved Labeled Indication: Adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
Exclusivity End Date: 01/29/2020 
Exclusivity Protected Indication* :  Adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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