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news.The FDA has delayed the approval process for Avanir Pharmaceuticals' new treatment for pseudobulbar affect having requested further information to support the drug's application.
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Pseudobulbar affect is a condition that sometimes affects multiple sclerosis sufferers, leaving them unable to control their emotions.
The agency requested that the company provide an expansion of certain summary analyses in its application for Neurodex to better support the new electronic data submission guidelines.
The company says that it will be meeting with the FDA 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 new drug application 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.