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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: miltefosine
Date Designated: 03/18/2009
Orphan Designation: Topical treatment of cutaneous lymphoma encompassing cutaneous manifestations of T-cell lymphoma and B-cell lymphoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
ExperGen Drug Development GmbH
Haupstrasse 24/16

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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.