MORRISTOWN, N.J., Oct. 18 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the US Food & Drug Administration to market Zolpidem Tartrate Extended-Release Tablets, USP 6.25mg CIV. Distribution of the product has commenced.
As the first company to file an ANDA that contained a paragraph IV certification for Ambien® CR 6.25mg, Actavis has been awarded 180-day exclusivity to market this product.
Zolpidem Tartrate Extended-Release Tablets 6.25mg, the generic equivalent of Ambien® CR 6.25mg by Sanofi-Aventis, had US sales of approximately $129 million for the 12 months ending June 30, 2010, according to IMS Health.
Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said:
"The approval of Zolpidem ER Tablets 6.25mg offers a significant value to our customers and patients. This approval, along with the first-to-file exclusivity, also underscores Actavis' emphasis and commitment to bringing complex controlled-release products to the marketplace."
Please see prescribing information at www.actavis.us/Zolpidem.
About Actavis Inc.
Actavis Inc. is the US 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 US 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.