The Food and Drug Administration requested further information regarding AbbVie's application for a neurotoxin aimed at facial aesthetics.
AbbVie said Thursday the FDA's complete response letter to its biologics license application for trenibotulinumtoxinE requested additional information about manufacturing processes. The letter didn't identify any safety or efficacy concerns for the neurotoxin, the company said.
AbbVie expects to submit a response in the coming months. The company said it believes trenibotulinumtoxinE has the potential to expand patients' options in facial aesthetics.
"Though disappointed, we remain confident in the strength and integrity of our application, and we are well positioned to respond to the agency's feedback promptly to support completion of the review," said Roopal Thakkar, executive vice president, research and development, chief scientific officer at AbbVie.
Regulatory reviews for the neurotoxin in other countries are ongoing and progressing as expected, AbbVie said.
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