Iceland-headquartered Actavis says that it has received two separate approvals from the US Food and Drug Administration to market bupropion HCl extended-release tablets. Distribution of the products will commence immediately.
Bupropion SR, available in 150mg strength, is the generic equivalent of Wellbutrin SR and are indicated for the treatment of major depressive disorder. The product is also the generic equivalent of Zyban for its indication as an aid to smoking cessation treatment. The drug for both uses was originated by UK-based drug giant GlaxoSmithKline.
Annual US sales of brand and generic Wellbutrin SR were $498.0 million for the 12 months ending December 2007, according to IMS Health data, and for Zyban they amounted to $12.0 million.
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