Topical treatment deemed safe enough to use without prescription

WASHINGTON —The FDA approved ivermectin (Sklice) lotion, 0.5%, previously a prescription treatment, as an over-the-counter (OTC) topical treatment for head lice infestation in patients age 6 months and older.

Ivermectin 0.5% was originally approved in February 2012 as a topical treatment for head lice infestation, which impacts 6 million-12 million children age 3-11 every year, the agency explained. Now, as a result of this “Rx-to-OTC switch,” the lotion will only be available to patients as an OTC therapy.

To make this shift, prescription drugs are required to provide evidence that the drug product is safe and effective when used as directed in the proposed product labeling, without the supervision of a healthcare 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, in a statement. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”

The FDA noted that ivermectin 0.5% is for external use only and should only be used on the scalp and dry hair, “in accordance with label directions.” The product is not currently approved for any other use.

Ivermectin 0.5% is manufactured by Arbor Pharmaceuticals LLC.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 725

Topic ID: 88,725,730,138,192,725,925