Posts tagged ‘ezogabine’

Ezogabine – PDUFA Date follow up

GSK and Valeant announced today that they have received a Complete Response Letter from the FDA that rejects their application for ezogabine for the treatment of epilepsy. This comes after the Advisory Committee recommend approval on August 11, 2011. 
The company releases are not very helpful in defining the reason for the rejection, only citing non-clinical issues that need to be resolved.   There was an earlier postponement of the PDUFA Date, so this may indicate the problem resides in the manufacturing area.  The company releases also indicate that the issues will be resolved in early 2011.