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Actavis Receives FDA Approval of Atomoxetine HCl Capsules for ADHD

Author: Actavis Inc.

Published: 2010-09-02

Synopsis and Key Points:

Actavis receives approval from FDA to market Atomoxetine HCl capsules for treatment of attention deficit hyperactivity disorder (ADHD).

Main Digest

Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder (ADHD).

Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths. No release date for Atomoxetine, Actavis' generic equivalent to Eli Lilly and Company's Strattera®, has been set. The U.S. Court of Appeals for the Federal Circuit is reviewing an Aug. 12 ruling that invalidated Lilly's patent, which is due to expire in 2017.

U.S. sales of Strattera® totaled $532 million for the 12-month period ended June 2010, 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 and Lincolnton, NC; and research and development facilities in Owings Mills, MD and Sunrise, FL. Please visit www.actavis.us for more information.

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.

Any statements contained in this press release that refer to Actavis' estimated or anticipated future results or future activities are forward-looking statements which reflect the Company's current analysis of existing trends, information and plans. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially depending on factors such as the availability of resources, the timing and effect of regulatory actions, the success of new products, the strength of competition, the success of research and development issues, unexpected contract breaches or terminations, exposure to product liability and other lawsuits, the effect of currency fluctuations and other factors.

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