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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
Trade Name: IMPAVIDO
Date Designated: 10/10/2006
Orphan Designation: Treatment of leishmaniasis.
Orphan Designation Status: Designated/Approved
Knight Therapeutics (USA)
Corporation Trust Center
1209 Orange Street
Wilmington, Delaware 19801
United States

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

Marketing approved:

1 Generic Name: miltefosine
Trade Name: IMPAVIDO
Marketing Approval Date: 03/19/2014
Approved Labeled Indication: Treatment of visceral leishmaniasis due to Leishmania donovani; cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis; and mucosal leishmaniasis due to Leishmania braziliensis.
Exclusivity End Date: 03/19/2021 
Exclusivity Protected Indication* :  Treatment of visceral leishmaniasis due to Leishmania donovani; cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis; and mucosal leishmaniasis due to Leishmania braziliensis.

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