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Home Industry News Lilly announces FDA approval of Cymbalta

Lilly announces FDA approval of Cymbalta

1st December 2009

Lilly revealed this week that the Food and Drug Administration (FDA) has approved its generalised anxiety disorder (GAD) treatment Cymbalta (duloxetine HC1).

Authorised for the maintenance treatment of GAD in adults, the efficacy and safety of Cymbalta was verified in a double-blind, placebo-controlled trial.

At the end of the study, candidates taking Cymbalta experienced a statistically significantly longer time to relapse than those administered a placebo.

The predicted probability of relapse at 26 weeks of maintenance treatment was 46.4 per cent for placebo and 15 per cent for Cymbalta.

James Martinez, medical director for Cymbalta, commented: “Since GAD can be a chronic illness, it is important that doctors and their patients find a treatment option that is effective in both the acute and maintenance phase[s].”

Last week, Lilly revealed that its antiplatelet medicine, Effient (prasugrel), was added as a treatment option in two clinical guideline updates.

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