{"id":106115,"date":"2023-08-03T15:52:35","date_gmt":"2023-08-03T10:22:35","guid":{"rendered":"https:\/\/tradebrains.in\/features\/?p=106115"},"modified":"2023-08-03T15:52:37","modified_gmt":"2023-08-03T10:22:37","slug":"zydus-lifesciences-gets-fda-final-approval-to-market-indomethacin-suppositories-for-rheumatoid-arthritis","status":"publish","type":"post","link":"https:\/\/tradebrains.in\/features\/zydus-lifesciences-gets-fda-final-approval-to-market-indomethacin-suppositories-for-rheumatoid-arthritis\/","title":{"rendered":"Zydus Lifesciences Gets FDA Final Approval To Market Indomethacin Suppositories for Rheumatoid Arthritis"},"content":{"rendered":"<div class=\"trade-content_2\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-2878108249\"><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>Zydus Lifesciences Ltd, is involved in development &amp; manufacture of formulations, biosimilars, biologics, APIs and intermediates. Zydus LifeSciences has 10 manufacturing facilities in APC &amp; Americas and 4 R&amp;D sites of which 2 are in India. It is the 4th largest Pharma company in India and a growing presence in other emerging markets in Asia and South America.<\/p><div class=\"trade-content_7\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-511923329\"><!-- 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><p><a href=\"https:\/\/portal.tradebrains.in\/stock\/ZYDUSLIFE\/consolidated\" target=\"_blank\" rel=\"noreferrer noopener\">Zydus Lifesciences<\/a> on Thursday, said it has received final approval from the US health regulator to manufacture and market its generic Indomethacin suppositories indicated for moderate to severe rheumatoid arthritis. The approval by the US Food and Drug Administration (USFDA) is for manufacturing and marketing of Indomethacin suppositories of 50mg strength, the company said in a regulatory filing. The company has been granted 180-day CGT (competitive generic therapy) exclusivity to market this product, it added. As per the USFDA, it may designate a drug as a CGT after determining that there is inadequate generic competition for that drug.<\/p><p>&#8220;We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition,&#8221; Zydus Lifesciences Managing Director Dr Sharvil Patel said.<\/p><p>Zydus said Indomethacin suppositories is a non-steroidal, anti-inflammatory drug indicated for moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and\/or tendinitis) and acute gouty arthritis. Citing IQVIA MAT April 2023 data, the company said Indomethacin suppositories 50mg had annual sales of approximately USD 95 million in the US.<\/p><div class=\"trade-content_5\" id=\"trade-1390079863\"><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><div class=\"trade-after-content\" id=\"trade-3997998751\"><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>Zydus Lifesciences Ltd, is involved in development &amp; manufacture of formulations, biosimilars, biologics, APIs and intermediates. Zydus LifeSciences has 10 manufacturing facilities in APC &amp; Americas and 4 R&amp;D sites of which 2 are in India. It is the 4th largest Pharma company in India and a growing presence in other emerging markets in Asia [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":42189,"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-106115","post","type-post","status-publish","format-standard","has-post-thumbnail","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>Zydus Lifesciences Gets FDA Final Approval To Market Indomethacin Suppositories for Rheumatoid Arthritis - Trade Brains Features<\/title>\n<meta name=\"description\" content=\"Zydus Lifesciences Ltd, is involved in development &amp; manufacture of formulations, biosimilars, biologics, APIs and intermediates. Zydus LifeSciences has 10 manufacturing facilities in APC &amp; Americas and 4 R&amp;D sites of which 2 are in India. It is the 4th largest Pharma company in India and a growing presence in other emerging markets in Asia and South America.\" \/>\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\/zydus-lifesciences-gets-fda-final-approval-to-market-indomethacin-suppositories-for-rheumatoid-arthritis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zydus Lifesciences Gets FDA Final Approval To Market Indomethacin Suppositories for Rheumatoid Arthritis\" \/>\n<meta property=\"og:description\" content=\"Zydus Lifesciences Ltd, is involved in development &amp; manufacture of formulations, biosimilars, biologics, APIs and intermediates. 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