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INDIANAPOLIS — Eli Lilly and Co. has obtained pediatric exclusivity for its antidepressant medication Cymbalta.
Lilly said Friday that it has met Food and Drug Administration requirements for pediatric exclusivity for Cymbalta (duloxetine HCl) and, as a result of the FDA decision, has gained another six months of U.S. market exclusivity for the drug.
The exclusivity period will now expire in December 2013, according to Lilly.
Lilly noted that the approval of pediatric exclusivity doesn’t mean Cymbalta is approved for use in children; the medication is FDA-approved only for use in patients age 18 and older. The company added that, based on study results, it won’t be seeking a pediatric indication for Cymbalta.
A serotonin and norepinephrine reuptake inhibitor (SNRI), Cymbalta comes in 20-mg, 30-mg and 60-mg capsules. The medication is indicated for the treatment of major depressive disorder and generalized anxiety disorder, as well as 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.
