Forest Labs Submits New Drug Application to FDA for Levomilnacipran
Forest Laboratories (NYSE: 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