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OTC Decisions August-October: More Providers Enter Diclofenac, Lansoprazole, Loratadine Markets

Executive Summary

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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