Actavis Group, the international generic pharmaceuticals company, today announced that it has received two separate approvals from the U.S. Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately.
Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Wellbutrin SR(R) and are indicated for the treatment of major depressive disorder. Annual sales of brand and generic Wellbutrin SR(R) were US$ 498 million for the 12 months ending December 2007 according to IMS Health data.
Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent of Zyban(R) and are indicated as an aid to smoking cessation treatment. Annual sales of brand and generic Zyban(R) were US$ 12 million for the 12 months ending December 2007 according to IMS Health data.
Commenting on the new approvals, Terry Fullem, Vice President of Marketing and Portfolio in the U.S. said:
"These approvals further enhance our strength in the area of modified release products and provide valuable options to our customers and patients."
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