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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Mitomycin-C
Date Designated: 08/20/1993
Orphan Designation: Treatment of refractory glaucoma as an adjunct to ab externo glaucoma surgery.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
IOP Inc.
3100 Airway Avenue, Suite 106
Costa Mesa, California 92626
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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