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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cyclosporine
Trade Name: Verkazia
Date Designated: 05/04/2007
Orphan Designation: Treatment of vernal keratoconjunctivitis
Orphan Designation Status: Designated/Approved
Harrow Eye, LLC
102 Woodmont Blvd Ste 610
Nashville, Tennessee 37205-2221
United States

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

Marketing approved:

1 Generic Name: cyclosporine
Trade Name: Verkazia
Marketing Approval Date: 06/23/2021
Approved Labeled Indication: Treatment of vernal keratoconjunctivitis (VKC) in children and adults
Exclusivity End Date: 06/23/2028 
Exclusivity Protected Indication* :  Treatment of vernal keratoconjunctivitis (VKC) in children and adults
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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