Yes, Jeuveau is FDA approved. The product received its initial FDA clearance in February 2019 via 510(k) pathway for the temporary improvement of moderate to severe glabellar lines (the vertical frown lines between the eyebrows) in adults. Jeuveau is manufactured by Evolus, a privately held aesthetics company, and represents the fourth FDA-cleared botulinum toxin Type A product to enter the U.S. market after Botox (AbbVie/Allergan), Dysport (Galderma), and Xeomin (Revance).

Approval Pathway and Regulatory Status