First OTC Diet Drug Receives Approvable Letter And Other Diet Drugs In Development
Xenical has passed the first hurdle to going over the counter. The FDA sent an approvable letter to GlaxoSmithkline regarding Alli the name for over-the-counter prescription drug Xenical. This will be the first approved weight loss drug to be sold OTC and will likely be a blockbuster in the huge weight loss market. Xenical has been available by prescription since 1999 and has world wide sales of about $500 million. Although GSK received an “approvable” letter the FDA has asked for more information but it evidently wasn’t much since the company has stated they will not need to submit any more human data. GSK hopes to have Alli in drugs stores before the end of the year. While GSK has licensed the rights for over-ther counter drug, Roche is the manufacturer and still has the prescription rights. This will be interesting since Sanofi-Aventis also has a diet drug called Rimonabant (It may be called Acomplia) in the works. Sanofi-Aventis has been asked for more information by the FDA and that may involve more human testing resulting in significant delays. The company hasn’t commented on what the FDA requested, but some financial houses downgraded Sanofi-Aventis back in February. Merck has also been investigating a drug similar to Sanofi’s known as only as “L-000899055″. Merck has been pretty silent regarding this drug. The weight loss industry should be an interesting to keep an eye on in the next couple of years.
Technorati Tags: FDA, weight loss
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