• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
Generic Name: Ganciclovir intravitreal implant
Trade Name: Vitrasert Implant
Date Designated: 06/07/1995
Orphan Designation: Treatment of cytomegalovirus retinitis.
Orphan Designation Status: Designated/Approved
Bausch & Lomb Surgical, Chiron Vision Products
9342 Jeronimo Road
Irvine, California 92718
United States

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

Marketing approved:

1 Generic Name: Ganciclovir intravitreal implant
Trade Name: Vitrasert Implant
Marketing Approval Date: 03/04/1996
Approved Labeled Indication: Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome.
Exclusivity End Date: 03/04/2003 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-