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