GlaxoSmithKline Weight-Loss OTC Drug Gets Go-Ahead

By Anya Sostek, Pittsburgh Post-Gazette

Feb. 8–GlaxoSmithKline’s Moon-based North American Consumer Healthcare Division gained government approval yesterday to sell weight loss drug orlistat over the counter.

The drug, to be marketed under the brand name Alli and slated to be available at stores this summer, is now the only weight-loss drug approved by the Food and Drug Administration for over-the-counter sales. Numerous herbal supplements that claim to promote weight loss do not require FDA approval and generate about a billion dollars in annual sales.

Orlistat, marketed in prescription form as Xenical, reduces the amount of fat that the intestines can absorb. For every five pounds that users lose from diet alone, orlistat can help them lose an additional two to three pounds, said Dr. Charles Ganley, who oversees non-prescription products at the FDA.

The North American Consumer Healthcare Division bought the rights to sell orlistat over the counter for $100 million in July of 2004.

An FDA advisory committee voted 11-2 to approve the drug in January of 2006, amid concerns about gastrointestinal side effects, possible use by minors and warnings on taking a nightly multivitamin and following a weight-loss program. “If someone chooses to just use orlistat alone without following a weight-loss program, then this drug is not going to be effective,” said Dr. Ganley.

—–

To see more of the Pittsburgh Post-Gazette, or to subscribe to the newspaper, go to http://www.post-gazette.com.

Copyright (c) 2007, Pittsburgh Post-Gazette

Distributed by McClatchy-Tribune Business News.

For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

GSK,