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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: meclorethamine
Trade Name: Valchlor
Date Designated: 08/17/2004
Orphan Designation: Treatment of mycosis fungoides
Orphan Designation Status: Designated/Approved
Helsinn Birex Pharmaceuticals Ltd.
Damastown
Mulhuddart, County Dublin
Ireland

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

Marketing approved:

1 Generic Name: meclorethamine
Trade Name: Valchlor
Marketing Approval Date: 08/23/2013
Approved Labeled Indication: Topical treatment of Stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
Exclusivity End Date: 08/23/2020 
Exclusivity Protected Indication* :  Topical treatment of Stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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