THURSDAY, March 20, 2014 (HealthDay News) -- Impavido (miltefosine) has been approved by the U.S. Food and Drug Administration to treat adults with leishmaniasis, a tropical disease caused by a parasite that's transmitted by the bites of sand flies.
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Most Americans who contract the disease do so traveling overseas, the agency said in a news release.
The drug's safety and effectiveness were evaluated in clinical trials involving more than 700 people. Impavido's label will include a boxed warning that the medication could harm a developing fetus and shouldn't be taken by pregnant women.
The drug is produced by Paladin Therapeutics, based in Montreal.
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