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Alli Approved OTC For Weight Loss With “Goal Oriented” Indication

This article was originally published in The Tan Sheet

Executive Summary

FDA's approved labeling for GlaxoSmithKline's first-in-class nonprescription weight-loss drug alli (orlistat 60 mg) emphasizes a "goal oriented" indication as opposed to a six-month duration of use as originally proposed

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OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.

For Successful OTC Switch Proposals, A Good Offense Defends Against Doubters

OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.

Room For Innovative Switches Could Lurk In Existing FDA Framework

When firms suggest submitting switch NDAs for “something that would be worth engaging on, we’re not going to tell you no,” says FDA nonprescription drug program chief Theresa Michele.

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