MORRISTOWN, N.J., May 18, 2012 /PRNewswire/ -- Actavis Group, an international generic pharmaceuticals company, today announced that it received US FDA approval of Ropinirole Extended-Release Tablets, 2mg, 4mg, 6mg, 8mg and 12mg, a generic equivalent to GlaxoSmithKline's Requip® XL. Actavis believes this is the first generic Requip® XL available in the US. Distribution of the product has commenced.
Requip® XL, 2mg, 4mg, 6mg, 8mg and 12mg, had US sales of approximately $59.4 million for the 12 months ending December 31, 2011, according to IMS Health.
Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said:
"The launch of Ropinirole Extended-Release Tablets showcases Actavis' commitment in bringing new products to market to benefit both patients and payors. We are proud to play a part in lowering healthcare costs through the introduction of quality generic products."
David Myers, Jr.
Senior Manager, Products & Communications
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 and packaging facilities in Elizabeth, NJ; a manufacturing facility in Lincolnton, NC; and research and development facilities in Owings Mills, MD and Sunrise, FL. Please visit www.actavis.us for more information.
Requip® XL is a registered trademark of a party other than Actavis.
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.