Lilly receives six months paediatric exclusivity for Cymbalta
10 July 2012 12:04 in Pharmaceutical Company Product News
Lilly has met the US regulatory requirements to obtain paediatric exclusivity for Cymbalta (duloxetine HC1), its treatment for major depressive disorder (MDD).
Following the decision by the US Food and Drug Administration (FDA), the company's market exclusivity for the drug will now expire in December 2013.
However, Cymbalta remains approved only for use in adult patients aged 18 and older. Lilly said it will not be seeking a paediatric indication for Cymbalta based on existing study results.
Pharmaceutical firms are sometimes granted six months of additional patent life on their therapies for conducting studies in children, as an incentive for carrying out more paediatric studies of their medicines.
Cymbalta is approved for the treatment of MDD and generalised anxiety disorder, as well as the management of diabetic peripheral neuropathic pain and fibromyalgia.
It can also be used to manage chronic musculoskeletal pain in people suffering from chronic osteoarthritis pain and chronic low back pain.
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