FDA Approves OTC Lotion to Treat Head Lice

A nonprescription lotion to treat head lice in patients 6 months of age or older has been approved by the US Food and Drug Administration (FDA). Ivermectin (Sklice) is a single-use lotion to treat infestations on the scalp and hair.

Head lice is a common infestation among children between the ages of 3 to 11 years. Children in childcare, elementary school, or members of a household that includes children with lice are typically affected. The US Centers for Disease Control and Prevention estimates between 6 and 12 million cases of head lice occur each year.

Ivermectin is a treatment that was originally approved in February 2012 for prescription use. The drug underwent a process called Rx-to-over-the-counter (OTC) switch to make it accessible to patients without needing a prescription from their health care provider. Following this approval, ivermectin will no longer be available as a prescription drug. Individuals who were previously prescribed ivermectin should reach out to their prescribing physician.

The process of switching a drug to nonprescription requires evidence of the safety and effectiveness of the drug, as well as the ability for consumers to understand how to use the product according to the Drug Facts and directions without the supervision of a professional. This process is usually initiated by the manufacturer of the drug. Arbor Pharmaceuticals LLC Is the manufacturer that has been granted approval for nonprescription Sklice.

“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research in a press release. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”

—Leigh Precopio

Reference:

FDA approves lotion for nonprescription use to treat head lice. News Release. October 27, 2020. US Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-lotion-nonprescription-use-treat-head-lice