Lilly gets 6 months exclusivity for Cymbalta

Singapore: Eli Lilly and Company met the US FDA requirements for pediatric exclusivity for Cymbalta (duloxetine HCl). Based on this decision by the FDA, Lilly has gained an additional six months of US 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.

Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI) that is available in 20 mg, 30 mg, and 60 mg capsules.