The Pharmaceutical Journal
Vol 278 No 7442 p271
10 March 2007

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GSK plans orlistat to be first pan-European OTC switch

GlaxoSmithKline is to try to get the anti-obesity drug orlistat listed as a non-prescription medicine throughout the EU.

A spokeswoman told The Journal this week that the company expects to apply to the European Medicines Agency by the end of the year for the product to be switched from prescription classification through the European centralised procedure. This will be the first time that the centralised system has been used for a prescription to non-prescription switch. If successful, GSK will be able to market the product in all EU countries without seeking separate national approvals.

Orlistat is already available over the counter in Australia and was approved for OTC marketing in the US last month. It is expected to be launched in the US in the summer.