Avanir Seeks European OK on Flagship DrugMonday, 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.