Over-the-counter weight loss drug gets 'approvable' letter from FDA

Over-the-counter weight loss drug gets 'approvable' letter from FDA

WASHINGTON - GlaxoSmithKline said on Friday that the Food and Drug Administration had written an "approvable" letter to its intention to sell a weaker version of its weight-loss drug Xenical. This means that the drug could start selling over-the-counter without the need for a prescription, but the company should first address some additional queries posed by the FDA.

Steven L. Burton, vice president for weight control products at Glaxo said that the British company was optimistic that the drug would hit the stores by the end of this year. The company did not elaborate on what queries were posed by the FDA; but said that the weaker form of the drug, called Alli, should get the requisite approval. "GSK Consumer Healthcare will work with the FDA to address their comments and recommendations," it said in a statement. Glaxo had purchased the U.S. rights for nonprescription sales of Xenical from the drug's maker Roche Holding AG in 2004.

The drug is already sold as a prescription drug since 1999, but has never been widely accepted since it causes adverse effects like diarrhea, oily stools and flatulence. Last year, the global sales of the drug accounted for $500 million. Clinical studies of a weaker version of the drug have shown that the weight loss effect of the drug is considerably more than those who do not take any medication. It was also found that 18 percent of those who took the drug lost 10 percent of their body weight. Glaxo estimates that about 6 million Americans would use the drug if it is sold over the counter.