Complete Response Letters
Revance Therapeutics, Inc.: daxibotulinumtoxinA
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Oct 14, 2021
Please refer to your biologics license application (BLA) dated November 24, 2019, received November 25, 2019, and your amendments, submitted under section 351 (a) of the Public Health Service Act for daxibotulinumtoxinA for injection.
CRL_BLA761127_20211014:p1:s10Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_BLA761127_20211014:p1:s16More Complete Response Letters
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