26 May 2016 - Vanda Pharmaceuticals today announced that the US FDA has approved Vanda's supplemental new drug application (sNDA) for Fanapt, modifying and expanding the prescribing information (PI) to describe the effectiveness of Fanapt as a maintenance treatment for schizophrenia in adults.
The FDA is also currently reviewing Vanda's application for three years marketing exclusivity based upon the REPRIEVE study submission and subsequent PI changes and expansion now approved in the sNDA.
For more details, go to: http://phx.corporate-ir.net/phoenix.zhtml?c=196233&p=RssLanding&cat=news&id=2172910