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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: paricalcitol
Trade Name: Zemplar
Date Designated: 10/27/2015
Orphan Designation: Treatment of pediatric hyperparathyroidism
Orphan Designation Status: Designated/Approved
Abbvie, inc.
1 North Waukegan Road
North Chicago, Illinois 60064
United States

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

Marketing approved:

1 Generic Name: paricalcitol
Trade Name: Zemplar
Marketing Approval Date: 10/18/2016
Approved Labeled Indication: Indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic kidney disease (CKD) Stages 3 and 4 and CKD Stage 5 in patients on hemodialysis or peritoneal dialysis
Exclusivity End Date: 10/18/2023 
Exclusivity Protected Indication* :  Indicated in pediatric patients ages 10 -16 years for treatment of secondary hyperparathyroidism associated with Chronic kidney disease (CKD) Stages 3 and 4 and pediatric patients ages 10-16 years for treatment of secondary hyperparathyroidism associated with CKD Stage 5.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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