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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: riboflavin ophthalmic solution & ultraviolet A
Trade Name: Photrexa Viscous
Date Designated: 09/02/2011
Orphan Designation: Treatment of keratoconus
Orphan Designation Status: Designated/Approved
Avedro, Inc.
230 Third Avenue
Waltham, Massachusetts 02451
United States

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

Marketing approved:

1 Generic Name: riboflavin ophthalmic solution & ultraviolet A
Trade Name: Photrexa Viscous
Marketing Approval Date: 04/15/2016
Approved Labeled Indication: Indicated for use in corneal collagen crosslinking in combination with the KXL¿ System for the treatment of progressive keratoconus
Exclusivity End Date: 04/15/2023 
Exclusivity Protected Indication* :  Treatment of progressive keratoconus

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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