Nicorette spray among proposed U.K. switches
This article was originally published in The Tan Sheet
Executive SummaryThe U.K. health authority considers applications to switch McNeil Products' Nicorette Nasal Spray smoking-cessation product from pharmacy to general sales status. In addition to the application from the Johnson & Johnson division operating in the U.K., the Medicines and Healthcare products Regulatory Agency seeks comments on P-to-GSL switch applications from Thornton & Rose for Hedrin Lotion (dimecticone) indicated for lice, and from Diomed Developments for Bazuka Treatment Gel (salicylic and lactic acids) for warts, verrucas, corns and calluses, and for Freederm Gel PL (nicotinamide) acne treatment. McNeil Products says since nicotine-replacement therapy patches, gum, lozenges and tablets already are available GSL in the U.K., the spray should be also. The firm says the 0.5 mg per-spray dose of the product is less than the maximum dose allowed for NRT products currently available GSL. Comments on each U.K. application are due by Oct. 29. In the U.S., NRT gum, lozenges and patches are available OTC, but not spray, according to FDA
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