FDA grants Impax tentative approval for generic Cymbalta NDA

Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration (FDA) has 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, U.S. sales of Cymbalta® capsules were approximately $3.0 billion for the 12 months ended September 30, 2010.

SOURCE Impax Laboratories, Inc.