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AbbVie Inc. (ABBV) Receives CRL from the FDA About the Biologics License Application for trenibotulinumtoxinE
AbbVie Inc. (ABBV) announced it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application for trenibotulinumtoxinE. The FDA’s request for additional information pertains to manufacturing processes and does not cite safety or efficacy concerns or require new clinical studies. AbbVie expressed confidence in addressing the FDA’s comments promptly and hopes to submit a comprehensive response in the coming months.