Xenical May be
Approved for Over The Counter Sales - Non-Prescription Version of
Orlistat May Win Approval By The FDA - Called Alli
April 7th 2006
The Food and Drug Administration (FDA) may approve an over the counter
(OTC) version of the prescription weight loss drug Xenical (orlistat).
The FDA issued an “approval letter” Friday which says the agency
believes the product is worthy of approval. Jennifer Corbett Dooren of
Marketwatch reported that there may be some conditions that need to be
met before the drug is allowed to market.
Xenical is marketed by Roche Holding AG, but the rights to the OTC
version were sold to the British firm, GlaxoSmithKline PLC's (GSK).
This is expected to be a weaker version of Xenical. The drug works by
preventing fat from being absorbed by the body. Some of the side
effects may include excess gas and an oily discharge.
If this drug ultimately wins approval, it would be the only weight loss
drug approved for OTC sales by the FDA. It is unknown what conditions
need to be met, but GSK said in a statement, "GSK Consumer Healthcare
will work with the FDA to address their comments and recommendations."