ARTICLE | Company News

GSK gets OTC orlistat approvable letter

April 8, 2006 1:50 AM UTC

GlaxoSmithKline (LSE:GSK; GSK) received an approvable letter from FDA for Alli orlistat 60 mg capsules as an over-the-counter product for weight loss. GSK would not disclose the terms for approval. The company still hopes to launch the product this year. GSK is seeking OTC approval of the lipase inhibitor to promote weight loss over a six-month period in overweight adults when used with a reduced calorie, low-fat diet. In January, FDA's Nonprescription Drugs Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee voted 11-3 to recommend OTC approval of the product. ...