RVNC - FDA accepts Revance's application resubmission for its injection to treat frown lines

Revance Therapeutics (NASDAQ:RVNC) on Thursday said the U.S. Food and Drug Administration (FDA) had accepted the company's application for resubmission of its DaxibotulinumtoxinA injection to treat moderate to severe glabellar (frown) lines. Despite the news, RVNC stock -11.2% to $15 in aftermarket trading. It had earlier closed -3% at $16.89. In October last year, the FDA had declined to approve the injection, citing deficiencies found during an inspection at RVNC's manufacturing facility. "The FDA designated the (Biologics License Application) as a class 2 resubmission, which has a six-month review period and includes a required reinspection of the company’s manufacturing facility," RVNC said on Thursday. The FDA set the so-called Prescription Drug User Fee Act date - or the date by which the regulator is set to decide on the application - as Sept. 8.

For further details see:

FDA accepts Revance's application resubmission for its injection to treat frown lines