In Latest US OTC Switch, Ivermectin 0.5% Lice Treatment Becomes Fully Nonprescription
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.
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From intranasal corticosteroids to a lice treatment, and from an addition to the OTC PPI market to the first nonprescription acne drug reaching the market through an NDA, US OTC switches in the past 10 years, since FDA began considering widening switch opportunities, haven’t lacked for variety.
National Advertising Division, in rare review of an Rx drug firm’s challenge of supplement ad claims, reported Innovix Pharma pulled health claims for OmegaVia brand supplements challenged by Amarin. Innovix prevailed in defending its labeling as accurate and its name as not false advertising.
Perrigo is the top potential marketer of the first OTC oral contraceptive in the US by acquiring HRA Pharma, which is preparing a switch NDA and earlier in 2021 gained UK regulatory approval for pharmacy sales of a progestin-only contraceptive, desogestrel.