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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Cysteamine hydrochloride
Trade Name: Cystaran
Date Designated: 08/19/1997
Orphan Designation: Treatment of corneal cystine crystal accumulation in cystinosis patients.
Orphan Designation Status: Designated/Approved
Leadiant Biosciences, Inc.
9841 Washingtonian Blvd
Suite 500
Gaithersburg, Maryland 20878
United States

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

Marketing approved:

1 Generic Name: Cysteamine hydrochloride
Trade Name: Cystaran
Marketing Approval Date: 10/02/2012
Approved Labeled Indication: Treatment of corneal cystine crystal accumulation in patients with cystinosis
Exclusivity End Date: 10/02/2019 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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