Showing posts with label Lurasidone. Show all posts
Showing posts with label Lurasidone. Show all posts

Monday, August 27, 2012

Health Canada approves Sunovion’s LATUDA NDA to treat schizophrenia

In continuation of my update on Lurasidone..

Health Canada approves Sunovion’s LATUDA NDA to treat schizophrenia: Sunovion Pharmaceuticals Canada Inc. today announced that the New Drug Submission (NDS) for LATUDA (lurasidone HCl), for the treatment of adult patients with acute schizophrenia has been approved by Health Canada.

Thursday, January 14, 2010

NDA of Lurasidone for Schizophrenia...

In continuation of my update on  Lurasidone, ........

Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.The efficacy of once-daily lurasidone was demonstrated in four six-week, placebo-controlled studies, involving hospitalized patients with schizophrenia. These studies included the global PEARL 1 and PEARL 2 clinical trials....

Ref : http://dsp-america.com/pdf/news/Lurasidone_NDA_Submission_PR_Jan_2010.pdf