Actavis Receives FDA Approval of Donepezil Hydrochloride Tablets in the U.S.
MORRISTOWN, N.J., May 31, 2011 /PRNewswire/ -- Actavis, an international generic pharmaceutical company, today announced that it has received approval from the US Food & Drug Administration to market Donepezil Hydrochloride Tablets a generic equivalent of AriceptŪ. Shipment will commence immediately.
Donepezil Hydrochloride Tablets 5mg and 10mg had US total sales of approximately $2.3 billion for the 12 months ending March 31, 2011, according to IMS Health.
Actavis Inc. is the US agent of Actavis Pharma Manufacturing Pvt. Ltd. which received the approval. 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 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.
Aricept Ū 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.