The Food and Drug Administration said GlaxoSmithKline's Alli is the first diet pill to be sold without a prescription.
Alli (pronounced "al-eye") is the brand name that has been given to low-dose Xenical (orlistat), the first drug in a new class of non-systemically acting anti-obesity drugs known as lipase inhibitors.
The intake of Alli reduces the absorption of some fat-soluble vitamins. It is advisable that your food is enriched with fat-soluble vitamins and beta-carotene. Over-the-counter dealings of Alli are proposed to be limited to adults 18 and over in an attempt to control mishandling by teenagers. Prior consultation with your doctor is recommended.
Alli is chemically no different from the existing prescription diet pill called Xenical, except that it contains only 50 percent less of a dosage of orlistat in Xenical(120 mg per capsule).
Xenical was approved by the FDA in 1999 to assist obese people to lose weight. It is the prescription form of the drug orlistat. Alli is not intended to replace Xenical, which remains available through a physician.
FDA officials said the approval offers an extra tool in the fight against obesity.
"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and Type 2 diabetes," said Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. "[Over-the-counter] orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."
The new drug will be sold by GlaxoSmithKline PLC and the company said it is expected to be in stores by summer. While the final price has not been determined, it is expected to be about $1- to $2-a-day.
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