GSK expedites OTC switch of Xenical

Could be the first over the counter drug that the FDA has ever approved for weight loss. GlaxoSmithKine has accelerated its timetable for the over-the-counter switch application of Xenical (orlistat) 60 mg after receiving positive feedback from the Food and Drug Administration, JP Garnier, chief executive officer of Glaxo, told analysts at the company’s fiscal 2004 annual review last week. JP Garnier feels that "Orlistat” is a really good opportunity for their consumer healthcare business. "This could be the first-ever, FDA-approved [OTC] weight loss agent in America,
Glaxo will be looking to file a lower-strength version of Roche’s prescription-strength Xenical, which is 120mg.

"That new formulation will be 60mg. and might avoid some of the side effects that are well-known and related to the prescription-strength product while not giving up much in terms of efficacy," Garnier said. Common side effects associated with Xenical include oily stools and gastronintestinal discomfort. GSK News Release

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