MORRISTOWN, N.J., Aug. 18 /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 Hydrochloride extended-release tablets (XL) 300mg. Distribution of the product will commence immediately.
Bupropion Hydrochloride extended-release tablets (XL), available in 300mg strength, are the generic equivalent of Wellbutrin XL(R) for the treatment of major depressive disorder. Annual US sales of brand and generic Wellbutrin XL(R) 300mg were US$581 million for the 12 months ending June 2008 according to IMS Health data.
Commenting on the new approval, Douglas Boothe, Chief Executive Officer of Actavis, Inc. said:
"Bupropion XL compliments our existing Buproprion SR offerings and expands the dosage options for our customers and patients. This approval also highlights Actavis Group's focus and expertise in bringing complex controlled-release technologies to the marketplace."
Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. With headquarters in Iceland, Actavis has operations in 40 countries, with 11,000 employees. The United States is the company's single largest market. Actavis' U.S. operations are located in New Jersey, Maryland, North Carolina and Florida.
More information about Actavis in the United States can be found at http://www.actavis.us.
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 Group|
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