"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, M.D., 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."
Rx-to-OTC switches are generally initiated by the manufacturer of the prescription drug. For a drug to switch from prescription to nonprescription status, the data provided must demonstrate that the drug is safe and effective when used as directed in the proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
In the United States, it is estimated that between 6 and 12 million cases of head lice infestation occur each year in children 3 to 11 years of age, according to the U.S. Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children and members of a household where children have lice.
Sklice is a single-use lotion with ivermectin 0.5% as the active ingredient, for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice is for external use only and should only be used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use.
Sklice will be marketed in the United States as a nonprescription drug and will no longer be available as a prescription drug. Consumers should read and follow the Drug Facts label for the nonprescription product. Patients who currently use prescription versions of this product should talk to their healthcare professional.
The FDA granted the approval of nonprescription Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice infestations in patients 6 months of age and older to Arbor Pharmaceuticals LLC.
Sklice, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use. The public can alert the FDA of any product being marketed or distributed with claims to prevent or cure COVID-19 by reporting the product to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov or 1-888-INFO-FDA (1-888-463-6332).
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
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