Actavis Receives Approval of Alprazolam ODT in the U.S.
MORRISTOWN, N.J., March 17 Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Alprazolam orally disintegrating tablets. Distribution of the product will commence immediately.
"We're very pleased to add Alprazolam ODT to our portfolio and complete our Alprazolam family of offerings, which also includes Alprazolam extended-release and immediate release tablets," said Actavis Inc. CEO Doug Boothe.
Alprazolam ODT, the generic equivalent of Niravam®, will be available in 0.25 mg, 0.5 mg, 1.0 mg, and 2.0 mg strengths. Alprazolam orally disintegrating tablets are indicated for the management of anxiety disorder or the short-term relief of symptoms of anxiety. U.S. sales of Niravam® and generic equivalents totaled $12.4 million for the 12 months ending December 2009, according to IMS Health data.
About Actavis Inc.
Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one quarter of Actavis' sales are generated in North America, Actavis' single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing facilities in Elizabeth, NJ; Little Falls, NJ; Totowa, NJ; and Lincolnton, NC. Actavis also has research and development facilities in Owings Mills, MD and Sunrise, FL; and a packaging facility in Totowa, NJ. For more information, please visit www.actavis.us.
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. For more information, please visit www.actavis.com.
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.
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