Eli Lilly and Company has met the United States Food and Drug Administration (FDA) requirements for paediatric 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 paediatric exclusivity does not mean that Cymbalta is approved for use in paediatric patients. Cymbalta is FDA-approved only for use in adults aged 18 and older. Based on study results, Lilly will not be seeking a paediatric indication for Cymbalta.
Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI). Cymbalta is available in 20-mg, 30-mg, and 60-mg capsules.
Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia. Cymbalta is also approved for the management of chronic musculoskeletal pain in people with chronic osteoarthritis pain or chronic low back pain.