Avanir addresses the FDA's concerns over Zenvia

Related Content

No related items were found.

ALISO VIEJO, Calif. Drug maker Avanir Pharmaceuticals has responded to the Food and Drug Administration’s concerns over a drug for treating a disease that causes bouts of laughter and crying in patients, Avanir said Friday.

Avanir said it issued a complete response to the FDA’s approvable letter from October 2006 for the drug Zenvia (dextromethorphan and quinidine), a treatment for pseudobulbar affect. “Approvable letter” is the former name for what the FDA began calling a “complete response letter” in 2008. A complete response letter means that the FDA has finished reviewing a drug company’s approval application, but questions remain that preclude final approval.

The company said it expected the FDA to grant it a review period of six months, allowing the approval of Zenvia in fourth quarter 2010.

© 2014 Drug Store News. All Rights Reserved.