| Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012. "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... | | | |
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