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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: acyclovir
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
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.

Marketing approved:

1 Generic Name: acyclovir
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.

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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