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Actavis Receives Approval of Bupropion HCl SR 100mg and 200mg in the U.S.

Thursday, July 22, 2010 Drug News J E 4
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MORRISTOWN, N.J., July 21 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Bupropion HCl Extended-Release (SR) tablets 100mg and 200mg.  Distribution of the product will commence immediately.  

Bupropion HCl SR Tablets, the generic equivalent of Wellbutrin® SR by GlaxoSmithKline, are now available from Actavis in the following strengths: 100mg, 150mg, and 200mg.  Bupropion HCl SR is used in the treatment of major depressive disorder.  Annual U.S. sales of Wellbutrin® SR 100mg and 200mg and the generic equivalent in that strength was US$115 million for the 12 months ending March 2010 according to IMS Health data. The addition of the 100mg and 200mg Bupropion HCl SR complements Actavis' already approved and marketed Bupropion HCl SR 150mg. Actavis received approval of Bupropion HCl SR 150mg in March, 2008.  

Commenting on the new approval, Michael Perfetto, Vice President of Sales & Marketing in the United States said:

"The approval of Bupropion SR 100mg and 200mg allows Actavis to provide the full range of strengths available on both Bupropion SR and XL products and offers a significant value to our customers and patients.  This approval also underscores Actavis' emphasis and commitment to bringing complex controlled-release products to the marketplace."

About Actavis Inc.

Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one third of Actavis' sales are generated in North America, Actavis' single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing facilities in Elizabeth, NJ and Lincolnton, NC. Actavis also has research and development facilities in Owings Mills, MD and Sunrise, FL.

About Actavis Group

Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals.  The company has operations in 40 countries, with more than 10,500 employees.

Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis.  By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.

SOURCE Actavis Inc.

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