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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: rosuvastatin
Trade Name: Crestor
Date Designated: 02/14/2014
Orphan Designation: For the treatment of pediatric homozygous familial hypercholesterolemia
Orphan Designation Status: Designated/Approved
iPR Pharmaceuticals, Inc.
1 MedImmune Way

Gaithersburg, Maryland 20878
United States

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

Marketing approved:

1 Generic Name: rosuvastatin
Trade Name: Crestor
Marketing Approval Date: 05/27/2016
Approved Labeled Indication: An adjunct to diet to reduce LDL-C, Total-C, nonHDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis).
Exclusivity End Date: 05/27/2023 
Exclusivity Protected Indication* :  An adjunct to diet to reduce LDL-C, Total-C, nonHDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis).

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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