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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FDA also approves packaging redesign for Mucinex and Mucinex-DM and final changes to labeling text and location on packaging. Granules Pharmaceuticals’ generic of Excedrin Migraine also among CDER’s decisions on OTC ANDAs and sNDAs during January-March.
Hisamitsu America launches Salonpas Arthritis Pain Relief Gel with same active ingredient, diclofenac sodium 1% gel, that became available OTC for the first time in the US in 2020 with GSK’s Voltaren Arthritis Pain formulation.
Natural Marketing Institute survey found capsules (42%) and tablets (41%) are most popular supplement formats followed by gummies (35%). Results presented during a Council for Responsible Nutrition webinar showed younger consumers are willing to try formats such as tinctures, oral sprays and tablets.