Orange County Business Journal

Avanir Seeks European OK on Flagship Drug

Vita Reed Monday, October 31, 2011

Aliso Viejo-based drug maker Avanir Pharmaceuticals Inc. announced that it is applying for European marketing authorization of its Nuedexta drug.

Nuedexta is used to treat a rare neurological disorder called pseudobulbar affect, which is marked by uncontrollable fits of laughing or crying. The Food and Drug Administration cleared Nuedexta a year ago.

Avanir began selling Nuedexta domestically in February.

The company said that the filling will start a validation process, which is expected to be completed in November. A scientific assessment and opinion review period is expected to follow and would take a minimum of 210 days, Avanir said.