Impax Laboratories, Inc. confirmed that the US Food and Drug Administration (FDA) had granted tentative approval of the company's Abbreviated New Drug Application for generic version of Cymbalta delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules. Eli Lilly and Company markets Cymbalta, a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia.

According to Wolters Kluwer Health, US sales of Cymbalta capsules were approximately $3.0 billion for the 12 months ended September 30, 2010.

Impax Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division.