Eli Lilly gains six months US pediatric exclusivity for Cymbalta
US drug major Eli Lilly (NYSE: LLY) announced that it has met the US Food and Drug Administration 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 - which generates annual sales of around $4 billion - is approved for use in pediatric patients. However, based on study results, Lilly says it will not be seeking a pediatric indication for Cymbalta.
Cymbalta is FDA-cleared only for use in adults aged 18 and older. It is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia. The drug is also approved for the management of chronic musculoskeletal pain in people with chronic osteoarthritis pain or chronic low back pain.
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