OTC sale for Xenical; Diet Drug; gets FDA approval

by Medindia Content Team on  April 8, 2006 at 6:47 PM Drug News   - G J E 4
OTC sale for Xenical; Diet Drug; gets FDA approval
Prescription diet drug Xenical manufactured by GlaxoSmithkline got a nod for OTC sale from FDA.It received an "approvable" letter from the Food and Drug Administration so that it can be marketed once the company addresses additional questions from regulators. An estimated arrival time for the sale is early next year.

It would become the first F.D.A.-approved weight-loss product sold without a doctor's prescription. The diet drug has been christened Alli.

A federal advisory panel voted 11 to 3 in January that the drug, which works by blocking fat absorption, could be sold without a prescription.

Although Xenical has been available as a prescription drug since 1999, it never got the star status partly because about half of the people who use it have episodes of diarrhoea, oily stools and flatulence because of fat that is excreted from the body rather than absorbed.

Clinical studies of the lower-dose over-the-counter version have shown that people using the drug lose more than their counterparts on similar diets who do not take the medication — an average of about five to six additional pounds more over six months. About 18 percent lose 10 percent or more of their initial body weight.

If it wins final approval, it would be the only FDA-endorsed weight-loss drug available without a prescription. But some experts express concern about people regaining weight after they stop using the drug, as well as whether people will be able to tell if it is safe for them without a doctor's advice. The drug can also lead to hepatitis, gallstones and kidney stones, although the exact cause is not clear.

But Gbola Amusa, an analyst in London for Sanford C. Bernstein & Company, said, "I'm assuming that the F.D.A. is addressing some things related to how they can ensure that this drug is not used inappropriately".

So the diet pill Xenical would soon be seen in shops.


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