Pharmabiz
 

Actavis gets US FDA nod to market generic Wellbutrin

Hafnarfjordar, IcelandWednesday, December 3, 2008, 08:00 Hrs  [IST]

Actavis has received approval from the US Food & Drug Administration (FDA) to market Bupropion Hydrochloride extended-release tablets (XL) 150mg. Distribution of the product has commenced. Bupropion Hydrochloride extended-release tablets (XL), available in 150 & 300mg strength, are the generic equivalent of Wellbutrin XL for the treatment of major depressive disorder. Annual US sales of brand and generic Wellbutrin XL were US$1,481 million for the 12 months ending September 2008 according to IMS Health data. Commenting on the new approval, Doug Boothe, CEO of Actavis in the United States said, "Bupropion XL 150mg, together with 300mg which was launched in August this year, offers significant value to our customers and patients. This approval also underscores Actavis' emphasis and capability in bringing complex controlled-release products to the marketplace."

 
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