FDA Sets October User Fee Date for Avanir’s PBA Drug Zenvia

The FDA has received Avanir Pharmaceuticals’ complete response for Zenvia, its leading experimental compound for the treatment of the neurological disorder pseudobulbar affect (PBA). The agency has classified Avanir’s package as a Class 2 response and given it an Oct. 30 user fee action date, Avanir said. PBA is a disorder causing patients to have spontaneous outbursts of emotional behavior, such as crying or laughing.
Washington Drug Letter