On Tuesday, the U.S. Food and Drug Administration (FDA) announced the approval of Sklice (ivermectin) lotion as nonprescription (OTC) use to treat head lice, through a process known as a “prescription (Rx)-to-OTC” switch.
In February 2012, the agency approved the lotion as a prescription drug for treating head lice infestation in patients above 6 months of age.
FDA’s Dr. Theresa Michele said, “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.”
“Today’s approval expands access to another effective topical treatment for the thousands of people with head lice,” added. Dr. Michele, who is the Acting Director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research.
Generally, the manufacturer of the prescription drug initiates the Rx-to-OTC switch. And for that switch, the manufacturer must provide enough data regarding the drug’s safety and efficacy on the product label. The manufacturer must also provide enough evidence to consumers about how to use the drug safely and effectively without the supervision of a doctor.
It is estimated that 6 to 12 million American children aged 3 to 11 suffer from head lice every year, according to the CDC.
Sklice comes in a single-use lotion for external use only, for patients above 6 months of age. It should only be used on the scalp and dry hair after going through the label directions. The FDA does not approve Sklice for any other medical use.
In the United States, Sklice will now be marketed as an OTC drug; it will no longer be available as a prescription drug. Arbor Pharmaceuticals received the approval of Sklice for nonprescription use of head lice treatment.