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.