Washington — The Food and Drug Administration (FDA) has approved Xeomin® (incobotulinumtoxinA, Merz Aesthetics) for temporary improvement of moderate to severe glabellar lines, Medscape Today reports.
According to a Merz statement, the approval is based on the results of two multicenter U.S. clinical trials involving 547 healthy adults. In both studies, Xeomin® injections significantly improved the appearance of glabellar lines in 30 days when compared with placebo. Headache was the most common adverse reaction observed.
Under the brand name Bocouture, Xeomin® is already approved in 14 European countries including Germany, the United Kingdom, France, Italy and Spain. It was FDA-approved in 2010 for the treatment of cervical dystonia and blepharospasm.
Xeomin® will be available nationwide in the spring of 2012, Merz officials said.