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The FDA approved the treatment through the prescription-to-OTC switch process.
The FDA has approved ivermectin 0.5% (Sklice; Arbor Pharmaceuticals LLC) lotion as an OTC treatment for head lice through the process of prescription (Rx)-to-OTC switch, according to a news release.
Ivermectin lotion, 0.5% was first approved by the FDA as a prescription drug for this indication in patients 6 months of age and older in February 2012.
Ivermectin 0.5% lotion is a single-use lotion for the topical treatment of head lice. As a result of this announcement, the treatment will no longer be available as a prescription drug, but rather will be offered over the counter.
There are an estimated 6 to 12 million cases of head lice in children ages 3 to 11 each year in the United States, according to the CDC, with cases most abundant in children in preschool, child care, and elementary school.
Rx-to-OTC switches occur when data show that the drug is safe and effective when used as directed in the proposed labeling; manufacturers must also prove that consumers can understand how to use the drug safely and effectively without the help of a health care professional.
“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. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”