|
 The company said the FDA pointed to "deficiencies" related to the
regulator's inspection of Revance's manufacturing site.
No other concerns were raised in the agency's "complete response
letter", the drug developer said.
Revance's DaxibotulinumtoxinA for Injection, a potential rival for
AbbVie Inc's Botox anti-wrinkle injection, was successful in
reducing moderate to severe frown lines in a late-stage study in
December 2018.
In November last year, the U.S. FDA delayed its decision on the
drug, as it was unable to conduct required inspection of the
company's manufacturing facility due to COVID-19 travel
restrictions. Revance later said it was expecting approval in 2021.
"We are very disappointed by this unanticipated response from the
FDA and are seeking further clarity from the agency," Mark Foley,
the chief executive officer of Revance, said in a statement on
Friday.
[to top of second column] |
 Revance said it plans to
request a meeting with the FDA as soon as
possible to address the agency's concerns.
The company's shares, which closed at $22.71 on
Friday, were at $16.20 in extended trade.
 (Reporting by Amruta Khandekar; Editing by Maju
Samuel)
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