somerset pharmaceuticals, inc. , a wholly owned subsidiary of mylan inc. , received approval from the fda for emsam® transdermal selegiline, on february 27 of 2006. Emsam® is the first transdermal treatment for major depressive disorder. All aspects of the emsam® product related to its design, chemistry, manufacturing and controls were the result of the integration of the talents and expertise of mti scientists. Emsam® is manufactured by mti.
antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (mdd) and other psychotic disorders. Anyone considering the use of emsam® or other antidepressants in a child or adolescent must balance this risk with the clinical need.
emsam® is not indicated for use in pediatric patients.
for additional details please see full prescribing information, including boxed warnings.