Paromomycin was considered at the 15th Expert Committee meeting in March 2007, where paromomycin solution for intramuscular (IM) injection was added to the Model List. The Expert Committee concluded that paramomycin was effective in terms of effect on standard endpoints, such as initial and final cure, for the treatment of visceral leishmaniasis in children and adults. Paromomycin is licensed in India, and was granted orphan drug designation by the US Food and Drug Administration (FDA) in March 2005 and the European Medicines Agency (EMEA) in April 2005. The EMLc Subcommittee endorsed the listing of paromomycin IM injection on the first EMLc.