for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up
Healthcare

BRIEF-Lundbeck says FDA accepts sNDA application for Rexulti labelling

Feb 8 (Reuters) - Lundbeck

* Says US Food and Drug Administration, FDA, has accepted for review Otsuka and Lundbeck’s supplemental New Drug Application (sNDA) filing for the proposed labelling update of Rexulti (brexpiprazole) for the maintenance treatment of schizophrenia

* Says anticipated date for FDA to complete its review of proposed expanded labelling, is 23 September 2016

* Says Rexulti was approved by the FDA in July 2015 as treatment for adults with schizophrenia and as an adjunctive treatment for major depressive disorder

* Says there are approximately 2.4 million adults in the United States with schizophrenia and around 75 pct of patients experience relapses where their symptoms come back or worsen Source text for Eikon: Further company coverage: (Reporting by Copenhagen Newsroom)

for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up