{"id":714838,"date":"2022-11-28T06:54:45","date_gmt":"2022-11-28T11:54:45","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/"},"modified":"2022-11-28T06:54:45","modified_gmt":"2022-11-28T11:54:45","slug":"ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/","title":{"rendered":"ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }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>ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP<\/b><\/p>\n<p>BAUDETTE, Minn.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nANI Pharmaceuticals, Inc. (\u201cANI\u201d or the \u201cCompany\u201d) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20 mg\/5 mL.\n<\/p>\n<p>\nANI\u2019s Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac<sup>\u00ae<\/sup>. The current annual U.S. market for Fluoxetine Oral Solution is approximately $14.6 million, according to IQVIA\/IMS Health, a leading healthcare data and analytics provider.\n<\/p>\n<p>\n&#8220;We continue to strengthen our generics business with new product launches, and laud the efforts of our R&amp;D team in helping the Company fulfill its ongoing commitment to provide affordable generic alternatives to customers and patients in need,\u201d stated Nikhil Lalwani, President and Chief Executive Officer of ANI.\n<\/p>\n<p><b>About ANI<\/b><\/p>\n<p>\nANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin<sup>\u00ae<\/sup> Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.anipharmaceuticals.com&amp;esheet=52979237&amp;newsitemid=20221128005162&amp;lan=en-US&amp;anchor=www.anipharmaceuticals.com&amp;index=1&amp;md5=4ef2012f82f6762bd55c0490f97ce44e\">www.anipharmaceuticals.com<\/a>.\n<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>\nTo the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company\u2019s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as \u201canticipates,\u201d \u201cwill,\u201d \u201cexpects,\u201d \u201cplans,\u201d \u201cpotential,\u201d \u201cfuture,\u201d \u201cbelieves,\u201d \u201cintends,\u201d \u201ccontinue,\u201d other words of similar meaning, derivations of such words and the use of future dates.\n<\/p>\n<p>\nUncertainties and risks may cause the Company\u2019s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials and other ingredients and supplies necessary for manufacture of our products; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining and maintaining product approval from the U.S. Food and Drug Administration; general business and economic conditions, including the ongoing impact of and uncertainties regarding the COVID-19 pandemic and inflationary pressures; market trends; products development; regulatory and other approvals and marketing.\n<\/p>\n<p>\nMore detailed information on these and additional factors that could affect the Company\u2019s actual results are described in the Company\u2019s filings with the Securities and Exchange Commission (\u201cSEC\u201d), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company\u2019s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20221128005162r1&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\/20221128005162\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20221128005162\/en\/<\/a><\/span><\/p>\n<p><b>Investor Relations:<br \/>\n<\/b><br \/>Lisa M. Wilson, In-Site Communications, Inc.<br \/>\n<br \/>T: 212-452-2793<br \/>\n<br \/>E: <a rel=\"nofollow\" href=\"mailto:lwilson@insitecony.com\">lwilson@insitecony.com<\/a><\/p>\n<p><b>Media:<br \/>\n<\/b><br \/>Faith Pomeroy-Ward, ANI Pharmaceuticals<br \/>\n<br \/>817-807-8044<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:Faith.pomeroyward@anipharmaceuticals.com\">Faith.pomeroyward@anipharmaceuticals.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Minnesota United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Health FDA General Health Research Science Pharmaceutical Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\" \/>\n","protected":false},"excerpt":{"rendered":"<p>ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP BAUDETTE, Minn.&#8211;(BUSINESS WIRE)&#8211; ANI Pharmaceuticals, Inc. (\u201cANI\u201d or the \u201cCompany\u201d) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20 mg\/5 mL. ANI\u2019s Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac\u00ae. The current annual U.S. market for Fluoxetine Oral Solution is approximately $14.6 million, according to IQVIA\/IMS Health, a leading healthcare data and analytics provider. &#8220;We continue to strengthen our generics business with new product launches, and laud the efforts of our R&amp;D team in helping the Company fulfill its ongoing commitment to &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP&#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-714838","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>ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP - 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\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP BAUDETTE, Minn.&#8211;(BUSINESS WIRE)&#8211; ANI Pharmaceuticals, Inc. (\u201cANI\u201d or the \u201cCompany\u201d) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20 mg\/5 mL. ANI\u2019s Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac\u00ae. The current annual U.S. market for Fluoxetine Oral Solution is approximately $14.6 million, according to IQVIA\/IMS Health, a leading healthcare data and analytics provider. &#8220;We continue to strengthen our generics business with new product launches, and laud the efforts of our R&amp;D team in helping the Company fulfill its ongoing commitment to &hellip; Continue reading &quot;ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2022-11-28T11:54:45+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20221128005162r1&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=\"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\\\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP\",\"datePublished\":\"2022-11-28T11:54:45+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\\\/\"},\"wordCount\":614,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20221128005162r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\\\/\",\"name\":\"ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP - 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(\u201cANI\u201d or the \u201cCompany\u201d) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Fluoxetine Oral Solution, USP 20 mg\/5 mL. ANI\u2019s Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac\u00ae. The current annual U.S. market for Fluoxetine Oral Solution is approximately $14.6 million, according to IQVIA\/IMS Health, a leading healthcare data and analytics provider. &#8220;We continue to strengthen our generics business with new product launches, and laud the efforts of our R&amp;D team in helping the Company fulfill its ongoing commitment to &hellip; Continue reading \"ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/","og_site_name":"Market Newsdesk","article_published_time":"2022-11-28T11:54:45+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20221128005162r1&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":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP","datePublished":"2022-11-28T11:54:45+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/"},"wordCount":614,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20221128005162r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/ani-pharmaceuticals-announces-the-fda-approval-and-launch-of-fluoxetine-oral-solution-usp\/","name":"ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP - 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