OTC Decisions August-October: More Providers Enter Diclofenac, Lansoprazole, Loratadine Markets
CDER’s August-September OTC application approvals are highlighted by Arbor Pharmaceuticals’ ivermectin 0.5% lice treatment. Orange Book changes also include four firms’ approvals for labeling to market generic equivalents of Voltaren Arthritis Relief launched as an OTC switch since earlier in 2020.
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Commissioners vote 3-2 that Mylan and Pfizer’s Upjohn can combine after divesting seven products; dissenting votes focus on price fixing allegations as commissioners Chopra and Slaughter criticize majority for not addressing government’s case against Pfizer and Mylan. Former FTC attorneys note that if Biden wins the presidential election, he could nominate one of the dissenters to FTC chair and give more traction to their views.
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.