Head lice infestation treatment, Sklice has been approved as a nonprescription or Over-the-Counter drug by the Food and Drug Administration, the regulator said in a statement.
Developed by privately held Arbor Pharmaceuticals Inc., Sklice (ivermectin) lotion, 0.5% was approved in 2012 for the treatment of head lice infestation in patients of 6 months of age and older as a prescription drug.
The nonprescription use approval was made through a process called prescription (Rx)-to-OTC switch.
"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.
For a drug to get switched from prescription to nonprescription status, it should be proved that the product is safe to use if the directions of use are properly followed and the method of use should be simple without needing the supervision of a healthcare professional.
According to Centers for Disease Control and Prevention, about 6 million to 12 million cases of head lice infestation take place in children between 3 and 11 years every year.
Sklice will be marketed as a nonprescription drug and will no longer be available as a prescription drug, the FDA said.
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