Forest Labs Submits New Drug Application to FDA for Levomilnacipran

Forest Laboratories FRX and Pierre Fabre Laboratories today announced that Forest has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for levomilnacipran, a serotonin norepinephrine reuptake inhibitor (SNRI) for the treatment of Major Depressive Disorder (MDD) in adults. Levomilnacipran was discovered by Pierre Fabre and jointly developed by Forest Laboratories and Pierre Fabre, under a licensing agreement in the U.S. and Canada. Pierre Fabre will be the active pharmaceutical ingredient (API) supplier. The application includes results from three positive Phase III studies comprising two double-blind, fixed-dose studies and one flexible-dose study evaluating the efficacy of levomilnacipran compared with placebo in adults with MDD. A See full press release