Six pharmaceutical companies have received approval from the Food and Drug Administration for the first generic versions of Eli Lilly's Cymbalta, a prescription medication used to treat depression and other conditions.


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First Cymbalta generics OK'd by FDA

December 12th, 2013

WASHINGTON – Six pharmaceutical companies have received approval from the Food and Drug Administration for the first generic versions of Eli Lilly's Cymbalta, a prescription medication used to treat depression and other conditions.

The FDA said Wednesday that it has cleared Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA and Torrent Pharmaceuticals Ltd. to market generic versions of Cymbalta (duloxetine delayed-release capsules) in various strengths.

"Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards," stated Kathleen Uhl, acting director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "Generic drugs offer greater access to health care for many people."

A selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), duloxetine is indicated for the treatment of major depressive disorder and general anxiety disorder.

The drug also may be used for the treatment of fibromyalgia, chronic muscle or joint pain, and pain from diabetic neuropathy.

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