Posted from: Thursday, March 07, 2019 - 10:40 AM - Present

Botox Competitor Jeuveau Approved

February 1, 2019 – The U.S. FDA has approved Jeuveau™ (prabotulinumtoxinA-xvfs) injection, manufactured by Evolus, to temporarily improve the appearance of moderate to severe glabellar lines (frown lines) associated with corrugator and/or procerus muscle activity in adults.

According to a press release, Jeuveau is the first FDA-approved neurotoxin used solely for aesthetic applications. The approval is based on a clinical study in which Jeuveau’s safety and efficacy were established.

Like other products derived from botulinum toxin, Jeuveau carries a black box warning that it may cause serious and potentially life-threatening side effects, including difficulty swallowing or speaking, and spread of toxin effects beyond the injection site. The product must be administered by a qualified healthcare professional. Recommended dosing calls for one intramuscular injection in each of five separate sites on the forehead. Jeuveau’s dosing units are not the same as or comparable to other botulinum products, and the total dose per treatment should not exceed 20 units. Treatments should be administered at least 90 days apart.

Evolus plans to launch Jeuveau in the spring of 2019. The list price is expected to be 20-30% less than that of competitor Allergan’s Botox® Cosmetic (onabotulinumtoxinA).

Last Updated Monday, March 18, 2019 - 01:40 PM.