Actavis Receives FDA Approval of Atomoxetine HCl Capsules

Actavis Receives FDA Approval of Atomoxetine HCl Capsules
MORRISTOWN, N.J., Sept 01, 2010 /PRNewswire via COMTEX/ -- 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(R), 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(R) 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.

Suggested Articles

Data from a 10,000-patient trial showed that people with osteoarthritis taking Novartis' Ilaris had 40% to 47% lower rates of joint replacements.

Immunic's lead asset beat placebo at reducing damage to myelin, which protects nerve fibers, in patients with relapsing multiple sclerosis.

The appointment sees Kobayashi switch from developing Dermira’s anti-IL-13 drug to advancing Aslan’s would-be rival.