Eli Lilly and Company has met the United States Food and Drug Administration (FDA) requirements for pediatric exclusivity for Cymbalta (duloxetine HCl), which is available in 20-mg, 30-mg, and 60-mg capsules.
As part of the approval, 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, a serotonin and norepinephrine reuptake inhibitor (SNRI), is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia.
The drug, which FDA approved only use in adults aged 18 and older, is used for the management of chronic musculoskeletal pain in people with chronic osteoarthritis pain or chronic low back pain.
