The FDA has issued a Complete Response Letter (CRL) regarding Revance Therapeutics Inc's (NASDAQ: RVNC) marketing application for DaxibotulinumtoxinA for Injection for moderate to severe glabellar (frown) lines.
The agency indicated deficiencies related to the FDA's onsite inspection at Revance's manufacturing facility.
Revance plans to request a Type A meeting with the FDA to address the deficiencies raised. No other deficiencies were identified in the CRL.
"We are very disappointed by this unanticipated response from the FDA and are seeking further clarity from the agency. We remain committed to bringing our next-generation neuromodulator product to market in both aesthetic and therapeutic indications," said Mark Foley, President and CEO.
Related content: Benzinga's Full FDA Calendar.
Price Action: RVNC shares are down 31.2% at $15.62 during the premarket session on the last check Monday.
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