{"id":811863,"date":"2025-02-12T02:04:02","date_gmt":"2025-02-12T07:04:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/indivior-statement-re-delayed-fda-approval-of-sublocade-label-changes\/"},"modified":"2025-02-12T02:04:02","modified_gmt":"2025-02-12T07:04:02","slug":"indivior-statement-re-delayed-fda-approval-of-sublocade-label-changes","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/indivior-statement-re-delayed-fda-approval-of-sublocade-label-changes\/","title":{"rendered":"Indivior Statement RE: Delayed FDA Approval of SUBLOCADE\u00ae Label Changes"},"content":{"rendered":"
\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n
\n RICHMOND, Va.<\/span>
\n <\/span>, Feb. 12, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Indivior PLC (Nasdaq\/LSE: INDV)\u00a0provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE\u00ae (buprenorphine extended-release) Injection, which was scheduled for February 7, 2025<\/span>:<\/p>\n

\n

\n
\n \"Indivior
\n <\/a>\n <\/p>\n<\/p><\/div>\n

\n Yesterday, February 11th<\/span>, the FDA informed Indivior that, following acceptance of the proposed label for SUBLOCADE, there were no outstanding items to address, but that final review of the SUBLOCADE label changes has been delayed.<\/i>\n <\/p>\n

\n Indivior will provide further updates on the status of the approval of the proposed SUBLOCADE label changes as appropriate. <\/i>\n <\/p>\n

\n \"Cision\" View original content to download multimedia:https:\/\/www.prnewswire.com\/news-releases\/indivior-statement-re-delayed-fda-approval-of-sublocade-label-changes-302374307.html<\/a><\/p>\n

SOURCE Indivior PLC<\/p>\n<\/p><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

PR Newswire RICHMOND, Va. , Feb. 12, 2025 \/PRNewswire\/ —\u00a0Indivior PLC (Nasdaq\/LSE: INDV)\u00a0provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE\u00ae (buprenorphine extended-release) Injection, which was scheduled for February 7, 2025: Yesterday, February 11th, the FDA informed Indivior that, following acceptance of the proposed label for SUBLOCADE, there were no outstanding items to address, but that final review of the SUBLOCADE label changes has been delayed. Indivior will provide further updates on the status of the approval of the proposed SUBLOCADE label changes as appropriate. View original content to download multimedia:https:\/\/www.prnewswire.com\/news-releases\/indivior-statement-re-delayed-fda-approval-of-sublocade-label-changes-302374307.html SOURCE Indivior PLC<\/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-811863","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nIndivior Statement RE: Delayed FDA Approval of SUBLOCADE\u00ae Label Changes - 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\/indivior-statement-re-delayed-fda-approval-of-sublocade-label-changes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Indivior Statement RE: Delayed FDA Approval of SUBLOCADE\u00ae Label Changes - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire RICHMOND, Va. , Feb. 12, 2025 \/PRNewswire\/ —\u00a0Indivior PLC (Nasdaq\/LSE: INDV)\u00a0provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE\u00ae (buprenorphine extended-release) Injection, which was scheduled for February 7, 2025: Yesterday, February 11th, the FDA informed Indivior that, following acceptance of the proposed label for SUBLOCADE, there were no outstanding items to address, but that final review of the SUBLOCADE label changes has been delayed. Indivior will provide further updates on the status of the approval of the proposed SUBLOCADE label changes as appropriate. 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