{"id":13874,"date":"2022-01-07T10:37:52","date_gmt":"2022-01-07T05:07:52","guid":{"rendered":"https:\/\/tradebrains.in\/features\/biz-alembic-pharma-usfda-2\/"},"modified":"2022-01-07T10:38:42","modified_gmt":"2022-01-07T05:08:42","slug":"biz-alembic-pharma-usfda-2","status":"publish","type":"post","link":"https:\/\/tradebrains.in\/features\/biz-alembic-pharma-usfda-2\/","title":{"rendered":"Alembic Pharma gets tentative USFDA approval for depressive disorder drug"},"content":{"rendered":"<div class=\"trade-content_2\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-4246160132\"><p><a href=\"https:\/\/tradebrains.in\/get\/telegram\/\"><img decoding=\"async\" class=\"alignnone wp-image-101992\" src=\"https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2023\/01\/telegram-channel-300x119.png\" alt=\"\" width=\"148\" height=\"59\" \/><\/a> <a href=\"https:\/\/news.google.com\/publications\/CAAqBwgKMN3Epgswxc--Aw?hl=en-IN&amp;gl=IN&amp;ceid=IN%3Aen\"><img decoding=\"async\" class=\"alignnone wp-image-123430\" src=\"https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2024\/05\/follow-on-google-news-300x82.png\" alt=\"follow-on-google-news\" width=\"222\" height=\"61\" srcset=\"https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2024\/05\/follow-on-google-news-300x82.png 300w, https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2024\/05\/follow-on-google-news-150x41.png 150w, https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2024\/05\/follow-on-google-news.png 468w\" sizes=\"(max-width: 222px) 100vw, 222px\" \/><\/a><\/p>\n<\/div><p>New Delhi, Jan 7 (PTI) Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine tablets indicated for the treatment of the major depressive disorder.\u00a0 \tThe tentative approval granted by the US Food &#038; Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Vortioxetine tablets of strengths in 5 mg, 10 mg, 15 mg and 20 mg, the company said in a statement.\u00a0 \tThese are therapeutically equivalent to the reference listed drug product (RLD) Trintellix tablets 5 mg, 10 mg, 15 mg, and 20 mg of Takeda Pharmaceuticals, USA, Inc, it added.<\/p><div class=\"trade-content_7\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-1252520695\"><!-- Composite Start --> \r\n <div id=\"M923760ScriptRootC1549812\"> \r\n <\/div> \r\n <script src=\"https:\/\/jsc.mgid.com\/t\/r\/tradebrains.in.1549812.js\" async> \r\n <\/script> \r\n <!-- Composite End --><\/div>\n<p>Citing IQVIA data, the company said these Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021.\u00a0 \tAlembic, however, said it is currently in litigation with H Lundbeck in the Court of appeals for the Federal Circuit and the launch of the product will depend on litigation outcome.\u00a0 \t&#8220;It is possible that our ANDA may not be indicated for certain uses due to unexpired exclusivities for the RLD for such uses,&#8221; the company said. PTI RKL  BAL BAL<\/p>\n<div class=\"trade-after-content\" id=\"trade-1386196520\"><div id=\"taboola-below-article-thumbnails\"><\/div>\r\n<script type=\"text\/javascript\">\r\n  window._taboola = window._taboola || [];\r\n  _taboola.push({\r\n    mode: 'alternating-thumbnails-a',\r\n    container: 'taboola-below-article-thumbnails',\r\n    placement: 'Below Article Thumbnails',\r\n    target_type: 'mix'\r\n  });\r\n<\/script>\r\n<script type=\"text\/javascript\">\r\n  window._taboola = window._taboola || [];\r\n  _taboola.push({flush: true});\r\n<\/script><\/div>","protected":false},"excerpt":{"rendered":"<p>New Delhi, Jan 7 (PTI) Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine tablets indicated for the treatment of the major depressive disorder.\u00a0 The tentative approval granted by the US Food &#038; Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[1696,31],"tags":[],"class_list":["post-13874","post","type-post","status-publish","format-standard","hentry","category-corporate-action","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.5 (Yoast SEO v25.0) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Alembic Pharma gets tentative USFDA approval for depressive disorder drug - Trade Brains Features<\/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:\/\/tradebrains.in\/features\/biz-alembic-pharma-usfda-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alembic Pharma gets tentative USFDA approval for depressive disorder drug\" \/>\n<meta property=\"og:description\" content=\"New Delhi, Jan 7 (PTI) Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine tablets indicated for the treatment of the major depressive disorder.\u00a0 The tentative approval granted by the US Food &#038; 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