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FDA Approves Updated Prescribing Information for NUEDEXTA

22-Jan-2015

The Food and Drug Administration (FDA) has approved updated prescribing information for NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate). The updated label, approved for use of as Jan. 20, includes a revised indications and usage statement on the approved use of NUEDEXTA, which is manufactured by Avanir Pharmaceuticals, Inc.

NUEDEXTA is used to treat Pseudobulbar Affect (PBA), a condition characterized by uncontrollable, sudden outbursts of crying and/or laughing that don’t usually match what a person is feeling on the inside. PBA can occur in people with brain injuries or certain other neurologic conditions, such as Alzheimer’s disease or multiple sclerosis.

Because the original label didn’t specifically mention brain injury or stroke, some people with brain injuries had difficulty getting the medication. “The Brain Injury Association of America has been urging the FDA to take this action for the last 18 months,” said Susan H. Connors, president and CEO of BIAA. “We are gratified that the agency listened and responded to our requests.” 

 
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