The Pharmaceutical Journal
Vol 279 No 7477 p519
10 November 2007

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EU-wide OTC orlistat licence sought by GSK

Reclassification of orlistat as a non-prescription medicine throughout the EU is being sought by GlaxoSmithKline. The company is the first to seek to use the European Medicines Agency’s centralised procedure to license an OTC medicine.

Orlistat 60mg was approved as an over-the-counter medicine by the US Food and Drug Administration earlier this year as an aid to weight loss.

Commenting on the European application, John Clarke, president of GSK Consumer Healthcare, said: “Obesity is a rapidly increasing problem and a significant burden for health care systems in Europe and elsewhere. . . . We hope to offer consumers a new, clinically proven option which can help to tackle this problem.”

He added that orlistat, sold OTC as Alli, was performing well in the US and that a similar marketing campaign would be used in Europe.