FDA approves Atomoxetine HCl capsules for ADHD

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.