Search Orphan Drug Designations and Approvals
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Generic Name: | alirocumab | ||||||||||||||||
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Trade Name: | Praluent | ||||||||||||||||
Date Designated: | 06/15/2017 | ||||||||||||||||
Orphan Designation: | Treatment of homozygous familial hypercholesterolemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, New York 10591 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | alirocumab |
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Trade Name: | Praluent | |
Marketing Approval Date: | 04/01/2021 | |
Approved Labeled Indication: | as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C | |
Exclusivity End Date: | 04/01/2028 | |
Exclusivity Protected Indication* : | as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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