Search Orphan Drug Designations and Approvals
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Generic Name: | Cysteamine hydrochloride | ||||||||||||||||
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Trade Name: | Cystaran | ||||||||||||||||
Date Designated: | 08/19/1997 | ||||||||||||||||
Orphan Designation: | Treatment of corneal cystine crystal accumulation in cystinosis patients. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | Cysteamine hydrochloride |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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