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.

OTC Regulatory Decisions Tracker US

More from Regulation

More from Policy & Regulation