Impax Laboratories has received tentative approval from the US Food and Drug Administration (FDA) for a generic version of Cymbalta (duloxetine hydrochloride) in 20mg, 30mg and 60mg delayed-release capsules.

Cymbalta is a serotonin and norepinephrine re-uptake inhibitor indicated for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, generalised anxiety disorder and fibromyalgia.

Cymbalta is marketed by Eli Lilly and Company. Sales of the drug in the US were approximately $3bn for the 12 months ending 30 September 2010.