MORRISTOWN, N.J., May 30, 2012 /PRNewswire/ -- Actavis Group, an international generic pharmaceuticals company, today announced that it received US FDA approval of Nifedipine Extended-Release Tablets, USP, 90mg, a generic equivalent to Bayer's Adalat® CC. Distribution of the product has commenced.
Nifedipine Extended-Release Tablets, USP, 90mg has sales of approximately $23 million for the 12 months ending December 31, 2011, according to IMS Health.
Commenting on the new approval, Mike Perfetto, Vice President of Sales & Marketing of Actavis Inc, said:
"The launch of Nifedipine Extended-Release Tablets, USP 90mg complements the Nifedipine Extended-Release 30mg and 60 mg tablets that we currently market. It is yet another example of Actavis' expertise in developing complex extended release products."
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.
Adalat® CC 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 Group