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Xenical

This article was originally published in The Tan Sheet

Executive Summary

"The proposed labeling for OTC orlistat (60 mg) indicates use for overweight adults, those are who 18 years or older. It is recommended that those under the age of 18 should seek the advice of their physician," GlaxoSmithKline states in a clarification of its statements on the Rx-to-OTC switch application for Xenical. Such a labeling approach is "very common in the OTC environment," the firm states, pointing to Rogaine Extra Strength for Men and Rogaine for Women as examples. GSK also mentions the possibility of developing "programs with retailers so that the age of the purchaser at the point of sale is verified," as is currently the case for OTC nicotine replacement therapy products such as Nicorette and NicoDerm CQ.In the meantime, GSK will "work with the FDA to finalize labeling and other post-marketing plans"...
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