Additional indication for Lilly's Cymbalta

The US Food and Drug Administration has approved drug major Eli Lilly's Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder in adults.

"Relapse, the re-emergence of depressive symptoms after a successful treatment of depression, is a significant clinical concern," says Doug Williamson, Cymbalta associate medical director for Lilly. "This approval from the FDA is important because data from our Cymbalta clinical trial demonstrate that continuing to treat the patient delays the time to possible relapse," he added.

The efficacy and safety of Cymbalta for maintenance treatment of major depression was established in a double-blind, placebo-controlled clinical trial. Patients with major depression in the trial (533 subjects) received the drug 60mg once daily.