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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: crinecerfont
Trade Name: Crenessity
Date Designated: 03/15/2019
Orphan Designation: Treatment of congenital adrenal hyperplasia
Orphan Designation Status: Designated/Approved
Neurocrine Biosciences, Inc.
12780 El Camino Real
San Diego, California 92130
United States

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

Marketing approved:

1 Generic Name: crinecerfont
Trade Name: Crenessity
Marketing Approval Date: 12/13/2024
Approved Labeled Indication: adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH)
Exclusivity End Date: 12/13/2031 
Exclusivity Protected Indication* :  adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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