FDA Approves Invermectin Lotion for Head Lice

The FDA has approved invermectin 0.5% (Sklice, Sanofi Pasteur Inc), a lotion for the treatment of head lice, for OTC use.

Invermectin 0.5% was initially approved for prescription use in patients 6 months of age and older in February 2012. Every year, an estimated 6 to 12 million cases of head lice infestation occurs in children 3 to 11 years of age, according to an FDA press release. Lice are most common among children in preschool, elementary school, and among members of a household in which children have lice.

The nonprescription designation was changed in a process known as prescription (RX)-to-OTC switch. This process is usually initiated by the manufacturer, which must prove that the drug is safe and effective when used as directed in the proposed labeling in order to be successful.

Invermectin 0.5% is a lotion for external use only and should be used on the scalp or dry hair in accordance with label instructions only. The lotion is not approved for any other use, according to the FDA.

“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,” Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”

The lotion will be marketed as a nonprescription drug and will no longer require a prescription drug. Those who are currently using a prescription version of the product should consult their health care professional, according to the FDA.

REFERENCE:

FDA Approves Lotion for Nonprescription Use to Treat Head Lice [News Release] October 27, 2020; White Oak, MD. https://www.fda.gov/news-events/press-announcements/fda-approves-lotion-nonprescription-use-treat-head-lice?utm_medium=email&utm_source=govdelivery. Accessed October 28, 2020