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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: povidone-iodine 0.5% (w/w) in dimethylsulfoxide 44% (w/w)
Date Designated: 05/11/2017
Orphan Designation: Treatment of microbial keratitis (which includes Acanthamoeba keratitis).
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Veloce BioPharma, LLC
7315 Wisconsin Avenue
Suite 400W
Chevy Chase, Maryland 20815
United States

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

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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