{"id":882132,"date":"2025-09-04T16:29:04","date_gmt":"2025-09-04T20:29:04","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/"},"modified":"2025-09-04T16:29:04","modified_gmt":"2025-09-04T20:29:04","slug":"amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/","title":{"rendered":"Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li>\n          <em>Another addition to Amneal\u2019s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals<\/em><br \/>\n          \n        <\/li>\n<\/ul>\n<p>BRIDGEWATER, N.J., Sept.  04, 2025  (GLOBE NEWSWIRE) &#8212; Amneal Pharmaceuticals, Inc. (\u201cAmneal\u201d or the \u201cCompany\u201d) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg\/vial, 25 mg\/vial, 37.5 mg\/vial and 50 mg\/vial, which references Janssen\u2019s Risperdal Consta<sup>\u00ae<\/sup>. The product is eligible for 180-day exclusivity under the FDA\u2019s Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025.<\/p>\n<p>Risperidone extended-release injectable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia or may be used alone or as an adjunctive therapy with lithium or valproate for the maintenance treatment of Bipolar I disorder.<\/p>\n<p>\u201cThis approval further strengthens our complex injectables portfolio with a new long-acting treatment option in mental health,\u201d said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. \u201cRisperidone extended-release injectable suspension requires advanced capabilities\u2014such as microsphere formulation and cold-chain manufacturing\u2014that underscore Amneal\u2019s leadership in developing and producing complex medicines. This milestone reflects our strong R&amp;D and manufacturing expertise and lays the foundation for future microsphere-based long-acting injectables.\u201d<\/p>\n<p>The most commonly reported adverse reactions for risperidone extended-release injectable suspension in clinical studies were headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increased, pain in extremity, and dry mouth. For full prescribing information, see the package insert <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=N_tFS_xQpmEiWe5VySSNg7AyZ2XAEToKXGYXpeJa9-b61OBJSfZNqsqr8hYGoueV49n8A6wQNz5cO7R_cpEkfZRCeRLP9xDwXIgsoTn4mqPpxE1mgvJUk8F94eUcXjWc\" rel=\"nofollow\" target=\"_blank\">here<\/a>.<\/p>\n<p>According to IQVIA<sup>\u00ae<\/sup> U.S. annual sales for risperidone extended-release injectable suspension for the 12 months ended July 2025 were approximately $194 million.<\/p>\n<p>\n        <strong>About Amneal<\/strong><br \/>\n        <br \/>Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=-sIyiMbHlqfHdqwtApcWKkekJrSYghDryl2_jPaoZSCbJvNL1LvleEQp6wIMwDsIz2dj1cDerrwp3WkfyjLkBWBR8QUnY_j0B-SRsArVpd5ng0sauB6EipTkBrcAHARROyZtUiq07Wc23WCuXqXFMdTIAeIdSHqci9QDExopy192aPLDKGGkkWB2mK6hFl0Osh51dJmxL8mX2RT6xRLwtt0t6Cb6--FW5cFWPo7sLkstsPqlcLyO4U7cG14MbSfKxjN8Ah9npzHzEWtnBp46u8pMftfdCQ5X4Bsrn1ewEkkhIKSXlxqlQiqZJsNda5pq\" rel=\"nofollow\" target=\"_blank\">www.amneal.com<\/a> and follow us on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=hjA9ZaZS_NBs-I6h5eaP3Ao32JZA1P3H1TzQPRhnDGw9SKcEFeyOcvdXuQMmQ_tf_lkJGG-L3DlYJMxEOyyZHnIDN33ubg-jmiqDk_-Bzz2Rq53SK8Fv30bjoxP2s-mt\" rel=\"nofollow\" target=\"_blank\">LinkedIn<\/a>.<\/p>\n<p>\n        <strong>Cautionary Statement on Forward-Looking Statements<\/strong><br \/>\n        <br \/>Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management\u2019s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as \u201cplans,\u201d \u201cexpects,\u201d \u201cwill,\u201d \u201canticipates,\u201d \u201cestimates,\u201d and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company\u2019s filings with the Securities and Exchange Commission, including under Item 1A, \u201cRisk Factors\u201d in the Company\u2019s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.<\/p>\n<p>\n        <strong>Investor Contact <\/strong><br \/>\n        <br \/>Anthony DiMeo<br \/>VP, Investor Relations <br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Y8QO9tZzFsc0zXSts0ys3JKjQs9PSZhD-8gR-j018fEX5VbpEFsme1FLR8V_xOdTyhOCcffFsSH1Qr71erof0ZghPJG02r6fsuUz6YTVVmmTSQxp_F7bwfH1TVczDc_T\" rel=\"nofollow\" target=\"_blank\">anthony.dimeo@amneal.com<\/a><\/p>\n<p>\n        <strong>Media Contact<\/strong><br \/>\n        <br \/>Brandon Skop<br \/>Sr. Director, Corporate Communications<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=u8c_NEcWJ0SonaWt6cClsbZFPexLxJ6yDA7yriN3FrbxMzTFYNU_OL779o-iY11nXIMsUgWsg7PKEC8q4DRUPR-WsHWN8_XDYAczBolc94s=\" rel=\"nofollow\" target=\"_blank\">Brandon.skop@amneal.com<\/a><\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUyMzU2NCM3MTMxMDg1IzIxOTA3Mzc=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/YzMwZGFiNjctMDJjYi00MjEyLTljZDAtMzk3MjhlYzAwZTNlLTEyMDIyOTAtMjAyNS0wOS0wNC1lbg==\/tiny\/Amneal-Pharmaceuticals-LLC.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Another addition to Amneal\u2019s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) &#8212; Amneal Pharmaceuticals, Inc. (\u201cAmneal\u201d or the \u201cCompany\u201d) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg\/vial, 25 mg\/vial, 37.5 mg\/vial and 50 mg\/vial, which references Janssen\u2019s Risperdal Consta\u00ae. The product is eligible for 180-day exclusivity under the FDA\u2019s Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025. Risperidone extended-release injectable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia or may be used alone or as an adjunctive therapy with lithium or valproate for the maintenance treatment of &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension&#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-882132","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension - 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\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Another addition to Amneal\u2019s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) &#8212; Amneal Pharmaceuticals, Inc. (\u201cAmneal\u201d or the \u201cCompany\u201d) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg\/vial, 25 mg\/vial, 37.5 mg\/vial and 50 mg\/vial, which references Janssen\u2019s Risperdal Consta\u00ae. The product is eligible for 180-day exclusivity under the FDA\u2019s Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025. Risperidone extended-release injectable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia or may be used alone or as an adjunctive therapy with lithium or valproate for the maintenance treatment of &hellip; Continue reading &quot;Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-04T20:29:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUyMzU2NCM3MTMxMDg1IzIxOTA3Mzc=\" \/>\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\\\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension\",\"datePublished\":\"2025-09-04T20:29:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\\\/\"},\"wordCount\":609,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTUyMzU2NCM3MTMxMDg1IzIxOTA3Mzc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\\\/\",\"name\":\"Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension - 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(\u201cAmneal\u201d or the \u201cCompany\u201d) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg\/vial, 25 mg\/vial, 37.5 mg\/vial and 50 mg\/vial, which references Janssen\u2019s Risperdal Consta\u00ae. The product is eligible for 180-day exclusivity under the FDA\u2019s Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025. Risperidone extended-release injectable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia or may be used alone or as an adjunctive therapy with lithium or valproate for the maintenance treatment of &hellip; Continue reading \"Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/","og_site_name":"Market Newsdesk","article_published_time":"2025-09-04T20:29:04+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUyMzU2NCM3MTMxMDg1IzIxOTA3Mzc=","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\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension","datePublished":"2025-09-04T20:29:04+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/"},"wordCount":609,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUyMzU2NCM3MTMxMDg1IzIxOTA3Mzc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension\/","name":"Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension - 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