Drug Development

U.S. FDA joint advisory committee recommends approval of weight loss drug for OTC use

Published in Medical Letter on the CDC and FDA, February 26th, 2006

Roche announced that the U.S. Food and Drug Administration's (FDA) joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee recommended (11 to 3) that orlistat 60 mg capsules be approved for over-the-counter use in the United States to promote weight loss in overweight adults, when used along with a reduced calorie, low-fat diet.

If approved by FDA, OTC orlistat, which GlaxoSmithKline Consumer Healthcare proposes to market under the brand name Alli, would be the only FDA-approved weight loss drug available over the counter. Alli would be indicated for use by overweight adults along with a reduced calorie, low-fat diet.

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Source: Medical Letter on the CDC and FDA (2006-02-26)

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