WELLBUTRIN GETS FIRST EUROPEAN APPROVAL

GlaxoSmithKline's (GSK) drug Wellbutrin XR has received a marketing license in the Netherlands, making it the first antidepressant of its kind to be approved in Europe, the company announced.

Wellbutrin XR (bupropion hydrochloride) is a nonadrenaline dopamine reuptake inhibitor that treats major depressive disorder in adults. The drug is an alternative to other antidepressants, such as selective serotonin reuptake inhibitors that have side effects including weight gain and sexual dysfunction, GSK said.

The company said it expected other European countries to license Wellbutrin XR in the first quarter of 2007 and that the product could be available as soon as April. The drug is already approvable in 21 other European countries, including Italy, Spain and Germany, GSK said.

In the U.S., the product is known as Wellbutrin XL and earned FDA approval in 2003. Biovail, the company responsible for the drug's domestic sales and distribution, sued the FDA last month for approving a generic version of Wellbutrin XL.