TGA (Australia) approval for Nuceiva to treat glabellar lines in Australia
Evolus, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has provided regulatory approval for Nuceiva (prabotulinumtoxinA), a neurotoxin dedicated exclusively to aesthetics
Nuceiva was approved for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients. Glabellar lines are the vertical lines between the eyebrows seen at maximum frown.
Evolus plans to launch Nuceiva in Australia during the second half of 2023 after commencing additional launches in Europe – beginning with Germany and Austria – in the first half of 2023. In addition to Great Britain, Nuceiva is also commercially available in Canada.
The safety and efficacy of Nuceiva was evaluated through the company's global TRANSPARENCY clinical program, which included two Phase III U.S. trials, the large head-to-head aesthetic pivotal study versus Botox (onabotulinumtoxinA) to date, and two long-term safety studies. The product is approved for sale in the U.S. under the brand name Jeuveau.
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