Search Orphan Drug Designations and Approvals
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| Generic Name: | Ganciclovir intravitreal implant | ||||||||||||||||
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| Trade Name: | Vitrasert Implant | ||||||||||||||||
| Date Designated: | 06/07/1995 | ||||||||||||||||
| Orphan Designation: | Treatment of cytomegalovirus retinitis. | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 1 | Generic Name: | Ganciclovir intravitreal implant |
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| 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* : | ||
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