INDIANAPOLIS — Eli Lilly announced that it has met Food and Drug Administration requirements for pediatric exclusivity for its antidepressant medication.
Based on this decision by the FDA, Lilly has gained an additional six months of U.S. market exclusivity for Cymbalta (duloxetine hydrochloride), which now will expire in December 2013.
Lilly noted, however, that the approval of pediatric exclusivity does not mean that the serotonin and norepinephrine reuptake inhibitor is approved for use in pediatric patients. Cymbalta only is approved for use in adults ages 18 years and older. Based on study results, Lilly will not be seeking a pediatric indication for Cymbalta, the drug maker said.