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US OTC Switch Drought Ends: FDA Approves GSK Arthritis Gel, Alcon Allergy Eye Drops

 
• By Malcolm Spicer

FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.

FDA Approved

Two years without OTC switches in the US soon could seem like the distant past after the Food and Drug Administration on one day announced its first approval of nonprescription sales for two ingredients – diclofenac sodium topical gel and olopatadine HCl ophthalmic solution/drops.

The agency on 14 February announced it approved a supplemental new drug application from GlaxoSmithKline PLC for OTC sales of diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain. It also approved an sNDA from Alcon Inc. for two formulations of olopatadine drops under

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