Drug news

Actavis and Gedeon Richter re-file NDA at FDA for RGH 188 (cariprazine) for Schizophrenia and Bipolar Disorder

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Last updated:7th Jan 2015

Published:7th Jan 2015

Source: Pharmawand

Actavis plc and Gedeon Richter Plc have announced that the FDA has acknowledged receipt of Actavis' New Drug Application (NDA) re-submission for its atypical antipsychotic cariprazine (RGH 188) a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors for treatment of Schizophrenia and Bipolar Disorder. The Prescription Drug User Fee Act (PDUFA) date is expected to be in the second quarter of 2015.

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