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news.Forest Laboratories has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for levomilnacipran, a serotonin norepinephrine reuptake inhibitor (SNRI) to treat Major Depressive Disorder (MDD) in adults.
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Pierre Fabre has discovered and jointly developed Levomilnacipran with the support of Forest Laboratories under a licensing agreement in the US and Canada.
Forest Laboratories has submitted the NDA application based on the results from three positive phase III studies comprising two double-blind, fixed-dose studies and one flexible-dose study, which evaluated evomilnacipran efficacy compared with placebo in adults with MDD.
Levomilnacipran, an enantiomer of racemic milnacipran, is an antidepressant and is protected by patent that extends through June 2023, without patent term extension.