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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: methotrexate
Date Designated: 10/04/2023
Orphan Designation: Treatment of non-infectious intermediate, posterior, or pan uveitis or chronic non-infectious anterior uveitis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Nordic Group B.V.
Siriusdreef 41
Hoofddorp 2132 WT
Netherlands

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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