News
Complete Response Letter for Daxibotulinumtoxin A for Injection to treat severe glabellar (frown) lines.
Revance Therapeutics, Inc. announced that the FDA has issued a Complete Response Letter, or CRL, regarding the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, for the treatment of moderate to severe glabellar (frown) lines.
In a communication received on October 15, the FDA has determined it is unable to approve the BLA in its present form, and indicated that there are deficiencies related to the FDA’s onsite inspection at Revance’s manufacturing facility. Revance plans to request a Type A meeting with the FDA as soon as possible to address the deficiencies raised. No other deficiencies were identified in the CRL.
Condition: Glabellar Lines
Type: drug
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