{"id":401722,"date":"2020-12-17T08:03:29","date_gmt":"2020-12-17T13:03:29","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=401722"},"modified":"2020-12-17T08:03:29","modified_gmt":"2020-12-17T13:03:29","slug":"eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\/","title":{"rendered":"Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution"},"content":{"rendered":"<h2>\nApplication Assigned a PDUFA Date of August 6, 2021<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p>DEER PARK, Ill., Dec.  17, 2020  (GLOBE NEWSWIRE) &#8212; Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company\u2019s new drug application (NDA) for topiramate oral solution. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of August 6, 2021.<\/p>\n<p>The application was submitted for three indications, including: monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older; and as preventative treatment of migraine in patients 12 years of age and older. Topiramate is one of Eton\u2019s three neurology-focused oral liquid product candidates that have been submitted to the FDA, and all three product candidates are expected to be approved and launched in 2021.<\/p>\n<p>\n        <strong>About Eton Pharmaceuticals<\/strong><br \/>\n        <br \/>Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI<sup>\u00ae<\/sup> SPRINKLE, Biorphen<sup>\u00ae<\/sup>, and Alaway Preservative Free<sup>\u00ae<\/sup>, and has six additional products that have been submitted to the FDA.<\/p>\n<p><strong>Forward-Looking Statements<\/strong><br \/>Statements contained in this press release regarding matters that are not historical facts are &#8220;forward-looking statements&#8221; within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton\u2019s business strategy, Eton\u2019s plans to develop and commercialize its product candidates, the safety and efficacy of Eton\u2019s product candidates, Eton\u2019s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton\u2019s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as &#8220;believes,&#8221; &#8220;anticipates,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;intends,&#8221; &#8220;will,&#8221; &#8220;goal,&#8221; &#8220;potential&#8221; and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton\u2019s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton\u2019s development programs and financial position are described in additional detail in Eton\u2019s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.<\/p>\n<p><strong>Company Contact:<\/strong><br \/>David Krempa<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=nbV4wrbXyKZQ8vs1athyA6l1N-gLfKuKwbHoTcD8q-8A00g0QR2qJUbBmt0gbO-03uXE13lcwG9sWuiyNJZibnAahbX-a1isAZ_Xu3r5WRg=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">dkrempa@etonpharma.com<\/a><br \/>612-387-3740<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExMzgxMCMzODg1ODE4IzIxMjI5ODQ=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/9d82f44a-fdc1-4436-99a5-36b64b8272b0\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Application Assigned a PDUFA Date of August 6, 2021 DEER PARK, Ill., Dec. 17, 2020 (GLOBE NEWSWIRE) &#8212; Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company\u2019s new drug application (NDA) for topiramate oral solution. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of August 6, 2021. The application was submitted for three indications, including: monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution&#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-401722","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution - 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-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Application Assigned a PDUFA Date of August 6, 2021 DEER PARK, Ill., Dec. 17, 2020 (GLOBE NEWSWIRE) &#8212; Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company\u2019s new drug application (NDA) for topiramate oral solution. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of August 6, 2021. The application was submitted for three indications, including: monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years &hellip; Continue reading &quot;Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-17T13:03:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExMzgxMCMzODg1ODE4IzIxMjI5ODQ=\" \/>\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=\"3 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\\\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution\",\"datePublished\":\"2020-12-17T13:03:29+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\\\/\"},\"wordCount\":547,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODExMzgxMCMzODg1ODE4IzIxMjI5ODQ=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/eton-pharmaceuticals-announces-acceptance-for-filing-of-new-drug-application-for-topiramate-oral-solution\\\/\",\"name\":\"Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution - 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