MORRISTOWN, N.J., July 5, 2012 /PRNewswire/ -- Actavis Group, an international generic pharmaceuticals company, announced that on June 29, 2012 it received tentative approval from the US Food and Drug Administration for Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg and 4mg, a generic equivalent to Shire's Intuniv®. Based upon available information, Actavis believes that it is the first applicant to file an ANDA for Intuniv® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act.
Intuniv® had US sales of approximately $342 million for the 12 months ending March 31, 2012, according to IMS Health.
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 Elizabeth, NJ, Owings Mills, MD and Sunrise, FL. Please visit www.actavis.us for more information.
Intuniv® 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