EMA Accepts MAA for PBA Therapy
The MAA is based on comprehensive clinical data from Avanir's controlled phase 3 studies of NUEDEXTA in patients with PBA.
Avanir Pharmaceuticals announced Thursday that the European Medicines Agency has accepted the filing of the Marketing Authorization Application for NUEDEXTA? (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect (PBA).
Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review.
NUEDEXTA was approved by the FDA in October 2010 for the treatment of PBA, a neurologic condition which is characterized by frequent outbursts of involuntary crying or laughing.
The MAA is based on comprehensive clinical data from Avanir's controlled phase 3 studies of NUEDEXTA in patients with PBA, plus data from t
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