Sunovion Pharmaceuticals Inc. Announces FDA Acceptance of 2 sNDAs for Latuda® as Monotherapy and Adjunctive Therapy in Adult Patients With Depressive Episodes Associated with Bipolar I Disorder
10/30/2012 7:07:13 AM
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) for the use of LATUDA as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression). The acceptance of these files indicates that the FDA has determined that the applications are sufficiently complete to permit a substantive review.