Amneal Resubmits New Drug Application for Migraine Treatment, Diabetes Drug Is Approved

Dow Jones2024-11-22

By Connor Hart

Amneal Pharmaceuticals resubmitted a new drug application for its migraine treatment to the Food and Drug Administration, and additionally received approval for its diabetes and obesity treatment.

The Bridgewater, N.J., company on Thursday said its migraine treatment, called dihydroergotamine, is a single-dose autoinjector that doesn't require refrigeration, assembly or priming. It can be self-administered by patients at home when experiencing cluster headaches or other tough-to-treat headaches.

Dihydroergotamine's original new drug application was rejected by the FDA due to facility inspection issues at a third-party site. To mitigate these concerns, Amneal said it transferred production of the drug in house.

The review is expected to be completed in the second quarter of 2025.

"We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches," Chief Commercial Officer Joe Renda said.

Also on Thursday, Amneal said it received FDA approval for its GLP-1 agonist -- a synthetic version of the hormone that regulates blood sugar, digestion and appetite, such as Ozempic and Rybelsus.

The company's GLP-1 agonist, called exenatide, was approved as a 1.2 milliliter or 2.4 milliliter pen injection, which the company said can be used as an adjunct to diet and exercise to help maintain blood-sugar levels in adults with type 2 diabetes.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

November 21, 2024 17:05 ET (22:05 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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/2485042948?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-11-22 06:05","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2485042948","market":"hk","top_or_hot":-1,"title":"Amneal Resubmits New Drug Application for Migraine Treatment, Diabetes Drug Is Approved","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Connor Hart \n</p>\n<pre>\n \n</pre>\n<p>\n  Amneal Pharmaceuticals resubmitted a new drug application for its migraine treatment to the Food and Drug Administration, and additionally received approval for its diabetes and obesity treatment. \n</p>\n<p>\n  The Bridgewater, N.J., company on Thursday said its migraine treatment, called dihydroergotamine, is a single-dose autoinjector that doesn't require refrigeration, assembly or priming. It can be self-administered by patients at home when experiencing cluster headaches or other tough-to-treat headaches. \n</p>\n<p>\n  Dihydroergotamine's original new drug application was rejected by the FDA due to facility inspection issues at a third-party site. To mitigate these concerns, Amneal said it transferred production of the drug in house. \n</p>\n<p>\n  The review is expected to be completed in the second quarter of 2025. \n</p>\n<p>\n  \"We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches,\" Chief Commercial Officer Joe Renda said. \n</p>\n<p>\n  Also on Thursday, Amneal said it received FDA approval for its GLP-1 agonist -- a synthetic version of the hormone that regulates blood sugar, digestion and appetite, such as Ozempic and Rybelsus. \n</p>\n<p>\n  The company's GLP-1 agonist, called exenatide, was approved as a 1.2 milliliter or 2.4 milliliter pen injection, which the company said can be used as an adjunct to diet and exercise to help maintain blood-sugar levels in adults with type 2 diabetes. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Connor Hart at connor.hart@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  November 21, 2024 17:05 ET (22:05 GMT)\n</p>\n<p>\n  Copyright (c) 2024 Dow Jones &amp; Company, Inc.\n</p>\n</font>","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>Amneal Resubmits New Drug Application for Migraine Treatment, Diabetes Drug Is Approved</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\">\nAmneal Resubmits New Drug Application for Migraine Treatment, Diabetes Drug Is Approved\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-22 06:05 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://dowjonesnews.com/newdjn/logon.aspx?AL=N><strong>Dow Jones</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>By Connor Hart \n\n\n \n\n\n  Amneal Pharmaceuticals resubmitted a new drug application for its migraine treatment to the Food and Drug Administration, and additionally received approval for its diabetes ...</p>\n\n<a href=\"https://dowjonesnews.com/newdjn/logon.aspx?AL=N\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"AMRX","symbol_name":"Amneal Pharmaceuticals, Inc.","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2485042948","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2485042948","pubTimestamp":1732226700,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Amneal Pharmaceuticals resubmitted a new drug application for its migraine treatment to the Food and Drug Administration, and additionally received approval for its diabetes and obesity treatment.The Bridgewater, N.J., company on Thursday said its migraine treatment, called dihydroergotamine, is a single-dose autoinjector that doesn't require refrigeration, assembly or priming. It can be self-administered by patients at home when experiencing cluster headaches or other tough-to-treat headaches.Dihydroergotamine's original new drug application was rejected by the FDA due to facility inspection issues at a third-party site. To mitigate these concerns, Amneal said it transferred production of the drug in house.The review is expected to be completed in the second quarter of 2025.\"We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches,\" Chief Commercial Officer Joe Renda said.Also on Thursday, Amneal s","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"AMRX":"Amneal Pharmaceuticals, Inc.","BK4007":"制药"},"translate_title":"Amneal重新提交治疗偏头痛新药申请，糖尿病药物获批","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AMRX":0.9},"content_text":"By Connor Hart \n\n\n \n\n\n  Amneal Pharmaceuticals resubmitted a new drug application for its migraine treatment to the Food and Drug Administration, and additionally received approval for its diabetes and obesity treatment. \n\n\n  The Bridgewater, N.J., company on Thursday said its migraine treatment, called dihydroergotamine, is a single-dose autoinjector that doesn't require refrigeration, assembly or priming. It can be self-administered by patients at home when experiencing cluster headaches or other tough-to-treat headaches. \n\n\n  Dihydroergotamine's original new drug application was rejected by the FDA due to facility inspection issues at a third-party site. To mitigate these concerns, Amneal said it transferred production of the drug in house. \n\n\n  The review is expected to be completed in the second quarter of 2025. \n\n\n  \"We are excited to be one step closer to providing a new ready-to-use solution for patients suffering from severe migraines and cluster headaches,\" Chief Commercial Officer Joe Renda said. \n\n\n  Also on Thursday, Amneal said it received FDA approval for its GLP-1 agonist -- a synthetic version of the hormone that regulates blood sugar, digestion and appetite, such as Ozempic and Rybelsus. \n\n\n  The company's GLP-1 agonist, called exenatide, was approved as a 1.2 milliliter or 2.4 milliliter pen injection, which the company said can be used as an adjunct to diet and exercise to help maintain blood-sugar levels in adults with type 2 diabetes. \n\n\n \n\n\n  Write to Connor Hart at connor.hart@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  November 21, 2024 17:05 ET (22:05 GMT)\n\n\n  Copyright (c) 2024 Dow Jones & Company, Inc.","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":1},"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":"4.29.4","shortVersion":"4.29.4","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/2485042948"}