Actavis Receives FDA Approval of Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV in the U.S.
MORRISTOWN, N.J., June 6, 2011 /PRNewswire/ — Actavis, an international generic pharmaceuticals company, today announced that it has received final approval from the US Food & Drug Administration to market Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV. Distribution of the product has commenced.
Actavis was the first company to launch Zolpidem Tartrate Extended-Release Tablets 6.25 mg strength in October 2010 with 180-day exclusivity.
Zolpidem Tartrate Extended-Release Tablets, the generic equivalent of AmbienÃ‚® CR , had US sales of approximately $793 million for the 12 months ending March 31, 2011, according to IMS Health.
Commenting on the new approval, Doug Boothe, CEO of Actavis in the US, said:
“The approval of Zolpidem ER Tablets 12.5 mg enables Actavis to offer both strengths to meet the needs of our customers. This approval also underscores Actavis’ emphasis and commitment to bringing complex controlled-release products to the marketplace to help improve patient access to pharmaceuticals.”
Please see prescribing information at www.actavis.us/Zolpidem.
About Actavis Inc.
Actavis Inc. is the US distributor of the product and the U.S. subsidiary of Actavis Group hf. Approximately one third of Actavis Group hf’s’ sales are generated in North America, Actavis’ single largest market. Based in Morristown, NJ, Actavis Inc. has U.S. manufacturing facilities in Elizabeth, NJ and Lincolnton, NC. Actavis also has research and development facilities in Elizabeth, NJ, Owings Mills, MD and Sunrise, FL.
Actavis Group hf 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.
AmbienÃ‚® is a trademark owned by 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.