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news.Avanir Pharmaceuticals, Avanir Holding and Center for Neurologic Study have sued Impax Laboratories in the District of Delaware over patents listed in connection with Nuedexta (dextromethorphan hydrobromide and quinidine sulfate 20mg / 10mg) capsules.
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Nuedexta is indicated for the treatment of pseudobulbar affect (PBA).
Impax has submitted a new drug application (ANDA) containing a paragraph IV certification for a generic version of Nuedexta with the US Food & Drug Administration (FDA).
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialize the product.