GlaxoSmithKline has received conditional approval for over-the-counter sales of the weight-loss drug Xenical, a Food and Drug Administration spokeswoman said Friday.
The British drugmaker received a letter from the FDA Thursday for the drug, which would be sold under the brand name Alli, FDA spokeswoman Laura Alvey said. She did not say what steps the company must take before it can win final approval.
Glaxo bought U.S. rights for nonprescription sales of Xenical from Roche Holding AG last year. Roche, the drug's maker, already sells Xenical by prescription.
Representatives for Glaxo could not be immediately reached for comment.
Known generically as orlistat, the pill helps prevent fat from being absorbed by the body but can cause excess gas and oily discharge.
If it wins final approval, it would be the only FDA-endorsed weight-loss drug available without a prescription.
Company officials have said nonprescription sales would help fight soaring obesity rates in the United States, making it easier for overweight Americans to seek treatment.
But some experts have expressed 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.
Orlistat is one of two main prescription obesity drugs on the U.S market. Its rival, Abbott Laboratories Inc's Meridia, suppresses appetite.