FDA close to approving GSK/Roche's number one obesity drug, Xenical, for OTC use

A US Food and Drug Administration joint advisory committee has recommended approval of the weight-loss drug Xenical (orlistat) 60mg capsules for over-the-counter use, giving it the potential to be the only non-prescription obesity treatment in the USA where 65% of the popluation is overweight or obese.

Swiss drug major Roche, which originated the drug, says that the FDA's joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee recommended 11 to three that low-dose capsules be approved for OTC use to promote weight loss in overweight adults, when used along with a reduced calorie, low-fat diet.

If approved, OTC orlistat will be sold under the brand name Alli (pronounced AL-eye). At the moment, the 120mg prescription strength of the drug is marketed in the USA by UK drug giant GlaxoSmithKline, which has been in talks with the FDA about the OTC switch.