{"id":766564,"date":"2023-06-28T06:56:30","date_gmt":"2023-06-28T10:56:30","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\/"},"modified":"2023-06-28T06:56:30","modified_gmt":"2023-06-28T10:56:30","slug":"eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\/","title":{"rendered":"Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection"},"content":{"rendered":"<div class=\"mw_release\">\n<p>DEER PARK, Ill., June  28, 2023  (GLOBE NEWSWIRE) &#8212; Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning. The issues raised in the CRL relate primarily to Chemistry Manufacturing and Controls (CMC). The Company believes all issues in the CRL are addressable and will develop a comprehensive action plan to address the FDA\u2019s concerns.<\/p>\n<p>\u201cWhile we are disappointed with the FDA\u2019s decision, our commercial business remains strong, and we are pleased that our momentum in product revenue growth has continued. We expect to once again report record product revenue in the second quarter of 2023. With the recent addition of Betaine Anhydrous for Oral Solution to our commercial product portfolio, we are well positioned for continued sustainable long-term growth,\u201d said Sean Brynjelsen, CEO of Eton Pharmaceuticals.<\/p>\n<p>\n        <strong>About Eton Pharmaceuticals<\/strong>\n      <\/p>\n<p>Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has three FDA-approved products in ALKINDI SPRINKLE\u00ae, Carglumic Acid tablets, and Betaine Anhydrous for oral solution, and four late-stage pipeline candidates under development with dehydrated alcohol injection, ZENEO\u00ae hydrocortisone autoinjector, ET-400, and ET-600. In addition, the Company receives royalties and is entitled to receive milestone payments on other products. For more information, please visit our website at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=v9S2DQ7ySaKYEmPTvM-yTVJH18YML2E7sQG_f9k7F_23QKMI21C3waKLLdvHlWV9jtDewu5__Is_l5l1DBV6w1eQqJXJCFz1aGxHKKBGtUI=\" rel=\"nofollow noopener\" target=\"_blank\">www.etonpharma.com<\/a>.<\/p>\n<p>\n        <strong>Investor Relations:<\/strong><br \/>\n        <br \/>Lisa M. Wilson, In-Site Communications, Inc.<br \/>T: 212-452-2793<br \/>E: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=zz7paD3jInl4mc18xYyVT6o20KkN0T3r9KU-4dBpcc1IHi5URbTD5XZyQvTf4TBZ_hvvDQ39j5iu_RLnQWQ-lJh85LGLufMm1PM6hHqoSDg=\" rel=\"nofollow noopener\" target=\"_blank\">lwilson@insitecony.com<\/a><\/p>\n<p>Source: Eton Pharmaceuticals.<\/p>\n<p \/>\n      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2NTg4NiM1NjY4NjY0IzIxMjI5ODQ=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/MjViY2I1OWItZDYwOC00OTVhLWFkMDgtMGMwOGY3ZGIzYzQ0LTExMzQ1NTU=\/tiny\/Eton-Pharmaceuticals.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>DEER PARK, Ill., June 28, 2023 (GLOBE NEWSWIRE) &#8212; Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning. The issues raised in the CRL relate primarily to Chemistry Manufacturing and Controls (CMC). The Company believes all issues in the CRL are addressable and will develop a comprehensive action plan to address the FDA\u2019s concerns. \u201cWhile we are disappointed with the FDA\u2019s decision, our commercial business remains strong, and we are pleased that our momentum in product revenue &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection&#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-766564","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>Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection - 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\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"DEER PARK, Ill., June 28, 2023 (GLOBE NEWSWIRE) &#8212; Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning. The issues raised in the CRL relate primarily to Chemistry Manufacturing and Controls (CMC). The Company believes all issues in the CRL are addressable and will develop a comprehensive action plan to address the FDA\u2019s concerns. \u201cWhile we are disappointed with the FDA\u2019s decision, our commercial business remains strong, and we are pleased that our momentum in product revenue &hellip; Continue reading &quot;Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-06-28T10:56:30+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2NTg4NiM1NjY4NjY0IzIxMjI5ODQ=\" \/>\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=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection\",\"datePublished\":\"2023-06-28T10:56:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\\\/\"},\"wordCount\":281,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODg2NTg4NiM1NjY4NjY0IzIxMjI5ODQ=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-receives-complete-response-letter-crl-for-dehydrated-alcohol-injection\\\/\",\"name\":\"Eton Pharmaceuticals Receives Complete Response Letter (CRL) for Dehydrated Alcohol Injection - 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