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.
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.
Common side effects include nausea, vomiting, diarrhea, headache, loss of appetite, dizziness, abdominal pain, itching, fatigue and elevated liver enzymes, the FDA said.
The drug is produced by Paladin Therapeutics, based in Montreal.