FDA committee approves weight loss drug orlistat for otc use
The US Food and Drug Administration's (FDA) joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee has recommended that orlistat 60 mg capsules be approved for otc use in the US.
The US Food and Drug Administration's (FDA) joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee has recommended that orlistat 60 mg capsules be approved for otc use in the US.
If approved by FDA, the drug, which GlaxoSmithKline Consumer Healthcare proposes to market under the brand name Alli (pronounced AL-eye), would be the only FDA-approved otc weight loss drug. It would be indicated for use by overweight adults in combination with a reduced calorie, low-fat diet.
GlaxoSmithKline Consumer Healthcare currently promotes prescription Xenical (orlistat 120mg) in the US through an agreement with Roche. Xenical will remain available on prescription for obesity management including weight loss and weight maintenance, and will continue to be marketed by Roche throughout the rest of the world.
Orlistat works locally in the gut by inhibiting the absorption of dietary fat. Help and advice on adopting a healthy eating plan will be provided in the Alli programme.