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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[F-D-C Reports' Pharmaceutical Approvals Monthly dissects drug reviews by FDA. While each drug stands or fails alone, a specific review can provide valuable insight into FDA's interpretation of data, policy and guidance documents, recurring controversies and resolution of internal disagreement. This story completes a two-part feature on alli.