FRIDAY, Oct. 30, 2020 (HealthDay News)
Sklice (ivermectin) lotion for treating head lice was approved for over-the-counter (OTC) use in a process known as prescription-to-OTC switch, the U.S. Food and Drug Administration announced Tuesday.
Sklice 0.5 percent was first approved in February 2012 for prescription use in the treatment of head lice infestation in patients ages 6 months and older. The OTC use approval of the single-use lotion with ivermectin 0.5 percent as the active ingredient is approved for topical use in the same patient population. It should only be used on the scalp and dry hair according to label directions. The lotion will no longer be available as a prescription treatment.
For prescription-to-OTC switches to be approved, the manufacturer needs to provide data that show “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 health care professional,” the FDA notes.
The approval was granted to Arbor Pharmaceuticals.
Physician’s Briefing Staff
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