BioCentury
ARTICLE | Company News

Avanir's Neurodex likely delayed again

September 22, 2005 11:38 PM UTC

AVN said an NDA for Neurodex to treat pseudobulbar affect (PBA) will likely be delayed again because FDA has requested an expansion of certain summary analyses. AVN said it expects FDA to reset the receipt date of the NDA to coincide with this submission. The company said it has the required data and will meet with the agency in the next few weeks to discuss the requested analyses. ...