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In Latest US OTC Switch, Ivermectin 0.5% Lice Treatment Becomes Fully Nonprescription

 
• By Malcolm Spicer

FDA approved Arbor Pharmaceuticals' sNDA for an OTC switch of Sklice lice treatment. As it's been prescribed since its 2012 approval, Sklice will be available as a single-use lotion for topical treatment of head lice infestations in patients six months of age and older.

Arbor Pharmaceuticals’ Sklice was approved for OTC sales after being the only Rx ivermectin 0.5% approved for lice treatment available in the US.

The US Food and Drug Administration’s fifth Rx-to-OTC switch approval in 2020, a lice treatment, doesn’t mark the substantial expansion in public health benefits that the agency and industry stakeholders envision for making drugs available nonprescription.

The FDA on 27 October said it approved a supplemental new drug application from Arbor Pharmaceuticals LLC for a full switch of its Sklice (ivermectin 0.5%) lice treatment to OTC

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