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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ganciclovir
Trade Name: Zirgan
Date Designated: 03/22/2007
Orphan Designation: Treatment of acute herpetic keratitis (dendritic and geographic ulcers)
Orphan Designation Status: Designated/Approved
Sirion Therapeutics, Inc.
9314 East Broadway Avenue
Tampa, Florida 33619
United States

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

Marketing approved:

1 Generic Name: ganciclovir
Trade Name: Zirgan
Marketing Approval Date: 09/15/2009
Approved Labeled Indication: Treatment of acute herpetic keratitis (dendritic ulcers)
Exclusivity End Date: 09/15/2016 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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