FDA Approves Avanir’s Drug Nuedexta

Nov. 3, 2010, 9:52 PM UTC

Avanir Pharmaceuticals Inc. Oct. 29 announced that the Food and Drug Administration has approved Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurological conditions and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying, the Aliso Viejo, Calif.-based company said. PBA episodes typically occur out of proportion or incongruent to the patient’s underlying emotional state.

Avanir said it expects that Nuedexta will be available by prescription during the first quarter of 2011.

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