The FDA announced its latest dermatologic therapy approval of over-the-counter (OTC) ivermectin lotion 0.5% for the treatment of head lice infestation in patients 6 months of age and older.
Ivermectin lotion, 0.5%, was initially approved as a prescription drug in February 2012. This latest approval follows a prescription-to-OTC switch process, which increases the availability of the lotion. These approval processes are generally initiated by the manufacturer and require data that demonstrate that the drug is safe and effective when used as directed by the consumer without the supervision of a health care professional.
In the United States, an estimated 6 to 12 million cases of head lice infestation occur annually in children ages 3 to 11 years. Infestations are common among child care settings, elementary schools, and households where children have lice.
FDA approves lotion for nonprescription use to treat head lice. News release. U.S. Food & Drug Administration; October 27, 2020. Accessed October 28, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-lotion-nonprescription-use-treat-head-lice