{"id":30244,"date":"2022-03-21T13:07:06","date_gmt":"2022-03-21T07:37:06","guid":{"rendered":"https:\/\/tradebrains.in\/features\/biz-alembic-pharma-usfda-4\/"},"modified":"2022-03-21T13:39:10","modified_gmt":"2022-03-21T08:09:10","slug":"biz-alembic-pharma-usfda-4","status":"publish","type":"post","link":"https:\/\/tradebrains.in\/features\/biz-alembic-pharma-usfda-4\/","title":{"rendered":"Alembic Pharma gets final USFDA approval for Lacosamide tablet"},"content":{"rendered":"<div class=\"trade-content_2\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-3939725092\"><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, Mar 21 (PTI) Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Lacosamide tablet, indicated for the treatment of partial-onset seizures in patients of 4 years of age and older.<\/p><div class=\"trade-content_7\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-1780049997\"><!-- 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>The approval by the US Food &#038; Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Lacosamide Tablets of strengths 50 mg, 100 mg, 150 mg, and 200 mg, the company said in a statement.<\/p>\n<p>The approved ANDA is therapeutically equivalent to the reference listed drug product Vimpat Tablets &#8212; 50 mg, 100 mg, 150 mg, and 200 mg &#8212; of UCB Inc, it added.<\/p>\n<p>&#8220;Lacosamide Tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses,&#8221; the company said.<\/p><div class=\"trade-content_5\" id=\"trade-2831367547\"><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-4023722985638610\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- in_content_2_news -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-4023722985638610\"\r\n     data-ad-slot=\"7925020301\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script><\/div>\n<p>Citing IQVIA data, the company said the Lacosamide tablets have an estimated market size of USD 1.67 billion for 12 months ending December 2021.<\/p>\n<p>Alembic said it has received 23 approvals year to date, including 16 final approvals and 7 tentative approvals &#8212; and a cumulative total of 161 ANDA approvals from USFDA. PTI RKL  BAL BAL<\/p>\n<div class=\"trade-after-content\" id=\"trade-1070987481\"><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, Mar 21 (PTI) Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Lacosamide tablet, indicated for the treatment of partial-onset seizures in patients of 4 years of age and older. The approval by the US Food &#038; Drug Administration (USFDA) is [&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-30244","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 final USFDA approval for Lacosamide tablet - 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-4\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alembic Pharma gets final USFDA approval for Lacosamide tablet\" \/>\n<meta property=\"og:description\" content=\"New Delhi, Mar 21 (PTI) Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Lacosamide tablet, indicated for the treatment of partial-onset seizures in patients of 4 years of age and older. 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