{"id":23835,"date":"2025-01-17T09:48:00","date_gmt":"2025-01-17T09:48:00","guid":{"rendered":"https:\/\/www.caplinpoint.net\/?p=23835"},"modified":"2025-01-22T08:52:08","modified_gmt":"2025-01-22T08:52:08","slug":"caplin-steriles-gets-usfda-approval-for-levetiracetam-in-sodium-chloride-injection-infusion-bags","status":"publish","type":"post","link":"https:\/\/www.caplinpoint.net\/index.php\/2025\/01\/17\/caplin-steriles-gets-usfda-approval-for-levetiracetam-in-sodium-chloride-injection-infusion-bags\/","title":{"rendered":"CAPLIN STERILES GETS USFDA APPROVAL FOR LEVETIRACETAM IN SODIUM CHLORIDE INJECTION, INFUSION BAGS"},"content":{"rendered":"\n<p><strong>Chennai, Jan 17, 2025: Caplin Steriles Limited (Caplin),<\/strong> a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Levetiracetam in Sodium Chloride Injection, 500mg\/100mL, 1000mg\/100mL and 1500mg\/100mL infusion bags (Large Volume Parenteral), a generic therapeutic equivalent version of the Reference Listed Drug (RLD), from HQ Speciality Pharma Corp. This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles, with a further 6 products under review with FDA for RTU Bags segment.<\/p>\n\n\n\n<p>Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adjunctive therapy \u2013 i) in the treatment of partial-onset seizures in adults with epilepsy, ii) in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy and iii) in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. According to IQVIATM (IMS Health), Levetiracetam in Sodium Chloride Injection had US sales of approximately $19 million for the 12-month period ending November 2024.<\/p>\n\n\n\n<div class=\"wp-block-file\"><a target=\"_blank\" href=\"https:\/\/www.caplinpoint.net\/wp-content\/uploads\/2024\/04\/Press_Release__sd-2.pdf\" class=\"wp-block-file__button\" rel=\"noopener\">Source<\/a><\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Chennai, Jan 17, 2025: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Levetiracetam in Sodium Chloride Injection, 500mg\/100mL, 1000mg\/100mL and 1500mg\/100mL infusion bags (Large Volume&#8230; <\/p>\n","protected":false},"author":1,"featured_media":1229,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/posts\/23835"}],"collection":[{"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/comments?post=23835"}],"version-history":[{"count":1,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/posts\/23835\/revisions"}],"predecessor-version":[{"id":23836,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/posts\/23835\/revisions\/23836"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/media\/1229"}],"wp:attachment":[{"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/media?parent=23835"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/categories?post=23835"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/tags?post=23835"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}