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Duloxetine was first synthesized in the late 1980s and subsequently patented in 1991. It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) and diabetic neuropathy in the third quarter of 2004. This long delay after the initiation of clinical investigations was the result of the drug’s initial testing in depressed patients at low dosages of 5–20 mg/day, which were not efficacious. Duloxetine has subsequently received approval almost worldwide.
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