What is the generic name?

MILTEFOSINE

What is the Trade Name for MILTEFOSINE?

IMPAVIDO

What are the Indications for MILTEFOSINE?

• 1 INDICATIONS AND USAGE IMPAVIDO (miltefosine) capsules are indicated in adults and pediatric patients 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for the treatment of: ‚Ä¢ Visceral leishmaniasis caused by Leishmania donovani [see Clinical Trials ( 14.1 )] . ‚Ä¢ Cutaneous leishmaniasis caused by Leishmania braziliensis , Leishmania guyanensis, and Leishmania panamensis [see Clinical Trials ( 14.2 )] . ‚Ä¢ Mucosal leishmaniasis caused by Leishmania braziliensis [see Clinical Trials ( 14.3 )] . Limitations of Use: ‚Ä¢ Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data [see Clinical Trials ( 14.1 , 14.2 )] . ‚Ä¢ There may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO [see Clinical Trials ( 14.1 , 14.2 )] . ‚Ä¢ The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated. IMPAVIDO is an antileishmanial drug indicated in adults and pediatric patients 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for the treatment of: ‚Ä¢ Visceral leishmaniasis due to Leishmania donovani ( 1 ). ‚Ä¢ Cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis ( 1 ). ‚Ä¢ Mucosal leishmaniasis due to Leishmania braziliensis ( 1 ). Limitations of use Leishmania species evaluated in clinical trials were based on epidemiologic data. There may be geographic variation in the response of the same Leishmania species to IMPAVIDO ( 1 , 14 ). The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.

References: https://open.fda.gov/