US FDA Declines to Approve Revance’s Frown-Line Treatment

Food and Drug Administration (FDA) headquarters in White Oak, Md., U.S. Andrew Kelly/Reuters

Revance Therapeutics Inc (RVNC.O) said on Friday the U.S. Food and Drug Administration had declined to approve its long-acting injectable drug to treat moderate to severe frown lines, sending its shares plunging 29 percent.

The company said the FDA pointed to “deficiencies” related to the regulator’s inspection of Revance’s manufacturing site.