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Treatment for Pseudobulbar Affect

Update: Nuedexta (dextromethorphan and quinidine) Now FDA Approved - October 29, 2010

Further Update on Avanir's Neurodex New Drug Application

SAN DIEGO, September 22, 2005 - Avanir Pharmaceuticals (AMEX:AVN) announced that during discussion with the U.S. Food and Drug Administration (FDA) yesterday regarding Avanir's new drug application (NDA) for Neurodex for the treatment of pseudobulbar affect (PBA), the Agency requested that the Company provide an expansion of certain summary analyses in its application to better support the new electronic data submission guidelines. The Company will be meeting with the Agency within the next few weeks to discuss the requested analyses. Based on these discussions, the Company expects that the FDA will reset the receipt date of the NDA filing to coincide with the Company's submission of this information.

"This delay is unfortunate, but we are very appreciative that the FDA is willing to work closely with us to make our application as complete and reviewable as possible," said Eric Brandt, President and CEO of Avanir.

Source: Avanir Pharmaceuticals

Posted: September 2005

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