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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Leuprolide acetate
Trade Name: Lupron Injection
Date Designated: 07/25/1988
Orphan Designation: Treatment of central precocious puberty
Orphan Designation Status: Designated/Approved
AbbVie Endocrine 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: Leuprolide acetate
Trade Name: Lupron Injection
Marketing Approval Date: 04/16/1993
Approved Labeled Indication: Treatment of children with central precocious puberty
Exclusivity End Date: 04/16/2000 
Exclusivity Protected Indication* :  
2 Generic Name: Leuprolide acetate
Trade Name: Lupron Depot-Ped
Marketing Approval Date: 04/14/2023
Approved Labeled Indication: treatment of pediatric patients with central precocious puberty (CPP)
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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