{"id":724981,"date":"2023-01-23T09:03:22","date_gmt":"2023-01-23T14:03:22","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/"},"modified":"2023-01-23T09:03:22","modified_gmt":"2023-01-23T14:03:22","slug":"evolus-receives-regulatory-approval-for-nuceiva-in-australia","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/","title":{"rendered":"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }\n.bwuline { text-decoration: underline }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Evolus Receives Regulatory Approval for Nuceiva<sup>\u00ae<\/sup> in Australia<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li class=\"bwalignc\"><i>Australia among the largest countries in the world for aesthetic neurotoxins<sup>1<\/sup><\/i><\/li>\n<\/ul>\n<p>NEWPORT BEACH, Calif.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nEvolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the Australian Therapeutic Goods Administration (TGA) has provided regulatory approval for Nuceiva<sup>\u00ae<\/sup> (prabotulinumtoxinA)\u25bc, a neurotoxin dedicated exclusively to aesthetics. Nuceiva<sup>\u00ae<\/sup> 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.\n<\/p>\n<p>\n\u201cWe are thrilled to gain regulatory approval for Nuceiva<sup>\u00ae<\/sup> in Australia, one of the largest market opportunities for aesthetic neurotoxins outside of the United States, where we are rapidly gaining market share, and Great Britain, where we recently launched commercial operations,\u201d said David Moatazedi, President and Chief Executive Officer, Evolus. \u201cThis approval is the latest example of our commitment to broaden our international presence, which is a key component to reaching our aspiration of $500 million in total revenue by 2028.\u201d\n<\/p>\n<p>\nEvolus plans to launch Nuceiva<sup>\u00ae<\/sup> in Australia during the second half of 2023 after commencing additional launches in Europe \u2013 beginning with Germany and Austria \u2013 in the first half of 2023. In addition to Great Britain, Nuceiva<sup>\u00ae<\/sup> is also commercially available in Canada.\n<\/p>\n<p>\nThe safety and efficacy of Nuceiva<sup>\u00ae<\/sup> was evaluated through the company\u2019s global TRANSPARENCY clinical program, which included two Phase III U.S. trials, the largest head-to-head aesthetic pivotal study versus BOTOX<sup>\u00ae<\/sup> (onabotulinumtoxinA) to date, and two long-term safety studies. The product is approved for sale in the U.S. under the brand name Jeuveau<sup>\u00ae<\/sup>.\n<\/p>\n<p><b>About Evolus, Inc.<\/b><\/p>\n<p>\nEvolus (Nasdaq: EOLS) is a performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau<sup>\u00ae<\/sup> (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure\u2122 technology. Visit us at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.evolus.com%2F&amp;esheet=53288783&amp;newsitemid=20230123005247&amp;lan=en-US&amp;anchor=www.evolus.com&amp;index=1&amp;md5=548067344c4f59c0db6b3b959e11c470\">www.evolus.com<\/a>, and follow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fevolusaesthetic&amp;esheet=53288783&amp;newsitemid=20230123005247&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=2&amp;md5=109f55a5fb96c726675dff03def602af\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FEvolusAesthetic&amp;esheet=53288783&amp;newsitemid=20230123005247&amp;lan=en-US&amp;anchor=Twitter&amp;index=3&amp;md5=eec288dc1b81ea8d4355b373f63242b9\">Twitter<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Fevolus%2F&amp;esheet=53288783&amp;newsitemid=20230123005247&amp;lan=en-US&amp;anchor=Instagram&amp;index=4&amp;md5=11552f192ccd4c55f0501ba455796473\">Instagram<\/a> or <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2Fevolusaesthetic%2F&amp;esheet=53288783&amp;newsitemid=20230123005247&amp;lan=en-US&amp;anchor=Facebook&amp;index=5&amp;md5=161996d092b76c0134965430f7f8d9b6\">Facebook<\/a>.\n<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>\nThis press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements based on our current expectations, assumptions, estimates and projections about future events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould\u201d or the negative of those terms, or other comparable terms intended to identify statements about the future. The company\u2019s forward-looking statements include, but are not limited to, statements related to the company\u2019s financial outlook in 2023 and beyond, expectations regarding share growth and international product launches.\n<\/p>\n<p>\nThe forward-looking statements included herein are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to uncertainties associated with our ability to comply with the terms and conditions in the Allergan\/Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, the continued impact of COVID-19 or other outbreaks of contagious diseases on our business, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Nuceiva\u00ae \/ Jeuveau\u00ae, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, our ability to successfully broaden our product portfolio, our ability to maintain regulatory approvals of Nuceiva\u00ae \/ Jeuveau\u00ae or obtain regulatory approvals for new product candidates or indications and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled \u201cRisk Factors\u201d in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the Securities and Exchange Commission on November 8, 2022. These filings can be accessed online at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sec.gov&amp;esheet=53288783&amp;newsitemid=20230123005247&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=6&amp;md5=56610cdf9b21b7719dfcae5cda88b69e\">www.sec.gov<\/a>. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If we do update or revise one or more of these statements, investors and others should not conclude that we will make additional updates or corrections.\n<\/p>\n<p>\n\u25bc This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.tga.gov.au%2Fsafety%2Freporting-problems&amp;esheet=53288783&amp;newsitemid=20230123005247&amp;lan=en-US&amp;anchor=Report+a+problem+or+side+effect&amp;index=7&amp;md5=6cb02d3525917538b9cfbe52cac240af\">Report a problem or side effect<\/a>.\n<\/p>\n<p><sup>1<\/sup>Sources: Medical Insights, Inc., DRG\/Clarivate and company estimates\n<\/p>\n<p>\nJeuveau<sup>\u00ae<\/sup> and Nuceiva<sup>\u00ae<\/sup> are registered trademarks of Evolus, Inc.<br \/>\n<br \/>Hi-Pure<sup>\u2122<\/sup> is a trademark of Daewoong Pharmaceutical Co, Ltd.<br \/>\n<br \/>BOTOX<sup>\u00ae<\/sup> is a registered trademark of Allergan, Inc.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230123005247r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20230123005247\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20230123005247\/en\/<\/a><\/span><\/p>\n<p><span class=\"bwuline\">Investor Contact:<br \/>\n<\/span><br \/>David K. Erickson, Evolus, Inc.<br \/>\n<br \/>Vice President, Investor Relations<br \/>\n<br \/>Tel: 949-966-1798<br \/>\n<br \/>Email: <a rel=\"nofollow\" href=\"mailto:david.erickson@evolus.com\">david.erickson@evolus.com<\/a><\/p>\n<p><span class=\"bwuline\">Media Contacts<\/span>:<br \/>\n<br \/>Maura Siefring<br \/>\n<br \/>Media Relations Lead<br \/>\n<br \/>Tel: 215-837-8450<br \/>\n<br \/>Email: <a rel=\"nofollow\" href=\"mailto:Maura.Siefring@uncappedcommunications.com\">Maura.Siefring@uncappedcommunications.com<\/a><\/p>\n<p>\nJanet Kettels<br \/>\n<br \/>International Communications Consultant, Evolus International<br \/>\n<br \/>Tel: +447738506476<br \/>\n<br \/>Email: <a rel=\"nofollow\" href=\"mailto:janet.kettels@evolus.com\">janet.kettels@evolus.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Australia\/Oceania Australia United States North America California<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Cosmetics Retail Pharmaceutical Health<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230123005247\/en\/1347984\/3\/LOGO.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia Australia among the largest countries in the world for aesthetic neurotoxins1 NEWPORT BEACH, Calif.&#8211;(BUSINESS WIRE)&#8211; Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the Australian Therapeutic Goods Administration (TGA) has provided regulatory approval for Nuceiva\u00ae (prabotulinumtoxinA)\u25bc, a neurotoxin dedicated exclusively to aesthetics. Nuceiva\u00ae 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. \u201cWe are thrilled to gain regulatory approval for Nuceiva\u00ae in Australia, one of the largest market opportunities for aesthetic neurotoxins outside of the United States, where &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-724981","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia Australia among the largest countries in the world for aesthetic neurotoxins1 NEWPORT BEACH, Calif.&#8211;(BUSINESS WIRE)&#8211; Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the Australian Therapeutic Goods Administration (TGA) has provided regulatory approval for Nuceiva\u00ae (prabotulinumtoxinA)\u25bc, a neurotoxin dedicated exclusively to aesthetics. Nuceiva\u00ae 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. \u201cWe are thrilled to gain regulatory approval for Nuceiva\u00ae in Australia, one of the largest market opportunities for aesthetic neurotoxins outside of the United States, where &hellip; Continue reading &quot;Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-01-23T14:03:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230123005247r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia\",\"datePublished\":\"2023-01-23T14:03:22+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\\\/\"},\"wordCount\":953,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20230123005247r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\\\/\",\"name\":\"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/","og_locale":"en_US","og_type":"article","og_title":"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia - Market Newsdesk","og_description":"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia Australia among the largest countries in the world for aesthetic neurotoxins1 NEWPORT BEACH, Calif.&#8211;(BUSINESS WIRE)&#8211; Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the Australian Therapeutic Goods Administration (TGA) has provided regulatory approval for Nuceiva\u00ae (prabotulinumtoxinA)\u25bc, a neurotoxin dedicated exclusively to aesthetics. Nuceiva\u00ae 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. \u201cWe are thrilled to gain regulatory approval for Nuceiva\u00ae in Australia, one of the largest market opportunities for aesthetic neurotoxins outside of the United States, where &hellip; Continue reading \"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/","og_site_name":"Market Newsdesk","article_published_time":"2023-01-23T14:03:22+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230123005247r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia","datePublished":"2023-01-23T14:03:22+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/"},"wordCount":953,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230123005247r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/evolus-receives-regulatory-approval-for-nuceiva-in-australia\/","name":"Evolus Receives Regulatory Approval for Nuceiva\u00ae in Australia - 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