FDA Approves Viatris Generic Version of Sandostatin LAR Depot

Reuters12-18 19:59

FDA Approves Viatris Generic Version of Sandostatin LAR Depot

Viatris Inc. has announced several recent regulatory milestones. The U.S. Food and Drug Administration (FDA) has approved Viatris' generic version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension). Additionally, the FDA has accepted the New Drug Application for Viatris' investigational low dose estrogen weekly patch for contraception, with a target action date set for July 30, 2026. The FDA has also cleared the Investigational New Drug application for MR-146, an AAV gene therapy candidate for neurotrophic keratopathy, with a Phase 1/2 clinical trial planned for the first half of 2026. In Japan, the Pharmaceuticals and Medical Devices Agency has accepted Viatris' New Drug Application for pitolisant in obstructive sleep apnea syndrome.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Viatris Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NE50233) on December 18, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2592908433?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-12-18 19:59","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2592908433","market":"us","top_or_hot":-1,"title":"FDA Approves Viatris Generic Version of Sandostatin LAR Depot","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Approves Viatris Generic Version of Sandostatin LAR Depot\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/VTRS\">Viatris Inc.</a> has announced several recent regulatory milestones. The U.S. Food and Drug Administration (FDA) has approved Viatris' generic version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension). Additionally, the FDA has accepted the New Drug Application for Viatris' investigational low dose estrogen weekly patch for contraception, with a target action date set for July 30, 2026. The FDA has also cleared the Investigational New Drug application for MR-146, an AAV gene therapy candidate for neurotrophic keratopathy, with a Phase 1/2 clinical trial planned for the first half of 2026. In Japan, the Pharmaceuticals and Medical Devices Agency has accepted Viatris' New Drug Application for pitolisant in obstructive sleep apnea syndrome.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Viatris Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NE50233) on December 18, 2025, and is solely responsible for the information contained therein.</span></i>\n</div></body></html>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>FDA Approves Viatris Generic Version of Sandostatin LAR Depot</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nFDA Approves Viatris Generic Version of Sandostatin LAR Depot\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-12-18 19:59</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA Approves Viatris Generic Version of Sandostatin LAR Depot\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        <a href=\"https://laohu8.com/S/VTRS\">Viatris Inc.</a> has announced several recent regulatory milestones. The U.S. Food and Drug Administration (FDA) has approved Viatris' generic version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension). Additionally, the FDA has accepted the New Drug Application for Viatris' investigational low dose estrogen weekly patch for contraception, with a target action date set for July 30, 2026. The FDA has also cleared the Investigational New Drug application for MR-146, an AAV gene therapy candidate for neurotrophic keratopathy, with a Phase 1/2 clinical trial planned for the first half of 2026. In Japan, the Pharmaceuticals and Medical Devices Agency has accepted Viatris' New Drug Application for pitolisant in obstructive sleep apnea syndrome.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Viatris Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NE50233) on December 18, 2025, and is solely responsible for the information contained therein.</span></i>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251218:nNDL75Nj2:1","article_id":"2592908433","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2592908433","pubTimestamp":1766059162,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Viatris Inc. has announced several recent regulatory milestones. The U.S. Food and Drug Administration  has approved Viatris' generic version of Sandostatin LAR Depot . Additionally, the FDA has accepted the New Drug Application for Viatris' investigational low dose estrogen weekly patch for contraception, with a target action date set for July 30, 2026. The FDA has also cleared the Investigational New Drug application for MR-146, an AAV gene therapy candidate for neurotrophic keratopathy, with a Phase 1/2 clinical trial planned for the first half of 2026. In Japan, the Pharmaceuticals and Medical Devices Agency has accepted Viatris' New Drug Application for pitolisant in obstructive sleep apnea syndrome.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, ","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","BK4583":"猴痘概念","BK4588":"碎股","BK4585":"ETF&股票定投概念","VTRS":"Viatris Inc."},"translate_title":"FDA批准善宁LAR Depot的Viatris仿制药","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VTRS":0.9},"content_text":"FDA Approves Viatris Generic Version of Sandostatin LAR Depot\n    \n\nViatris Inc. has announced several recent regulatory milestones. The U.S. Food and Drug Administration (FDA) has approved Viatris' generic version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension). Additionally, the FDA has accepted the New Drug Application for Viatris' investigational low dose estrogen weekly patch for contraception, with a target action date set for July 30, 2026. The FDA has also cleared the Investigational New Drug application for MR-146, an AAV gene therapy candidate for neurotrophic keratopathy, with a Phase 1/2 clinical trial planned for the first half of 2026. In Japan, the Pharmaceuticals and Medical Devices Agency has accepted Viatris' New Drug Application for pitolisant in obstructive sleep apnea syndrome.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Viatris Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NE50233) on December 18, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.35.12","shortVersion":"4.35.12","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2592908433","isCrawlerRequest":true}