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Avanir Pharma Nuedexta gets FDA approval

Avanir Pharmaceutical has received US Food and Drug Administration (FDA) approval for Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.

Avanir Pharma president and CEO Keith Katkin said that the FDA approval of Nuedexta marks an important milestone for people living with PBA.

"The approval of Nuedexta also marks Avanir’s transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA," Katkin said.

"We expect that Nuedexta will be available by prescription during the first quarter of 2011."