Lilly obtains six months U.S. pediatric exclusivity for Cymbalta®

Eli Lilly and Company (NYSE: LLY) announced today that it has met the United States Food and Drug Administration (FDA) requirements for pediatric exclusivity for Cymbalta® (duloxetine HCl). Based on this decision by the FDA, Lilly has gained an additional six months of U.S. market exclusivity for Cymbalta, which now will expire in December 2013.

The approval of pediatric exclusivity does not mean that Cymbalta is approved for use in pediatric patients. Cymbalta is FDA-approved only for use in adults aged 18 and older. Based on study results, Lilly will not be seeking a pediatric indication for Cymbalta.