Search Orphan Drug Designations and Approvals
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| Generic Name: | acyclovir | ||||||||||||||||
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| Trade Name: | Avaclyr | ||||||||||||||||
| Date Designated: | 12/13/2010 | ||||||||||||||||
| Orphan Designation: | Treatment of acute herpetic keratitis caused by Herpes Simplex Virus type 1 and 2 | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Fera Pharmaceuticals 134 Birch Hill Road Locust Valley, New York 11560 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: | acyclovir |
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| Trade Name: | Avaclyr | |
| Marketing Approval Date: | 03/29/2019 | |
| Approved Labeled Indication: | AVACLYR is a sterile topical antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus. | |
| Exclusivity End Date: | 03/29/2026 | |
| Exclusivity Protected Indication* : | AVACLYR is a sterile topical antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus. | |
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