{"id":26041,"date":"2022-06-21T12:21:11","date_gmt":"2022-06-21T11:21:11","guid":{"rendered":"https:\/\/ferringglobal.corporate.ferring.tech\/?p=26041"},"modified":"2022-06-22T10:24:25","modified_gmt":"2022-06-22T09:24:25","slug":"ferring-statement-on-minirin-octostim-ddavp-stimate-desmopressin-nasal-spray","status":"publish","type":"post","link":"https:\/\/www.ferring.com\/ferring-statement-on-minirin-octostim-ddavp-stimate-desmopressin-nasal-spray\/","title":{"rendered":"Ferring Statement on Minirin\u00ae \/ Octostim\u00ae \/ DDAVP\u00ae \/ Stimate\u00ae (desmopressin) Nasal Spray"},"content":{"rendered":"[spb_boxed_content type=”coloured” box_link_target=”_self” padding_vertical=”0″ padding_horizontal=”0″ width=”1\/1″ el_position=”first last”]\n<h2 style=\"color: #0088ce\">Ferring Statement on Minirin\u00ae\/Octostim\u00ae\/DDAVP\u00ae\/Stimate\u00ae (desmopressin) Nasal Spray<\/h2>\n[\/spb_boxed_content] [spb_blank_spacer height=”30px” width=”1\/1″ el_position=”first last”] [spb_boxed_content type=”coloured” box_link_target=”_self” padding_vertical=”0″ padding_horizontal=”0″ width=”1\/1″ el_position=”first last”]\n<p><strong>Saint-Prex, Switzerland \u2013 21 June, 2022 \u2013 Minirin\u00ae (desmopressin) Nasal Spray 0.1 mg\/ml room temperature stable (RTS)\/ Octostim\u00ae (desmopressin) Nasal Spray 1.5 mg\/ml\/ DDAVP\u00ae (desmopressin acetate, 10 mcg\/0.1 mL)\/ Stimate\u00ae (desmopressin acetate, 1.5 mg\/1 mL) Nasal Spray\/ Generic Desmopressin Acetate (10 mcg\/0.1mL) Nasal Spray \u2013 Recall and Production Hold Statement<\/strong><\/p>\n<p>Following the detection of out-of-specification results during testing, in 2020 Ferring initiated a precautionary voluntary global recall of all batches of the following products:<\/p>\n<ul>\n<li>Minirin\u00ae (desmopressin) Nasal Spray 0.1 mg\/ml room temperature stable (RTS) formulation<\/li>\n<li>Octostim\u00ae (desmopressin) Nasal Spray 1.5 mg\/ml<\/li>\n<li>DDAVP\u00ae (desmopressin acetate, 10 mcg\/0.1 mL)<\/li>\n<li>Stimate\u00ae (desmopressin acetate, 1.5 mg\/1 mL) Nasal Spray<\/li>\n<li>Generic Desmopressin Acetate (10 mcg\/0.1mL) Nasal Spray<\/li>\n<\/ul>\n<p>Following investigation, the root cause of the out-of-specification results was identified as a tightness issue with the primary packaging materials.<\/p>\n<p>In order to resolve this issue, new machinery is required and a new assembly process will need to be designed and validated. Based on the timelines needed to procure, install and qualify a new production line, we expect to start manufacturing Minirin\u00ae Nasal Spray Room Temperature Stable (RTS) 0.1 mg\/ml and Octostim\u00ae (desmopressin) Nasal Spray 1.5 mg\/ml in Q2 of 2023. Dependent on regulatory submission and approval timelines, deliveries to first markets are now expected from mid-2024 due to additional stability data required.<\/p>\n<p>Ferring is committed to ensuring that our medicines adhere to the highest quality standards for our patients, and to working with health authorities to ensure alternatives for patients. Any patients or caregivers with concerns or questions about treatment alternatives should immediately contact their treating physician.<\/p>\n<p>If you have additional questions, please find contact details of regional Ferring teams below:<\/p>\n<p><strong><em><u>US and Canada<br \/>\n<\/u><\/em><\/strong>If you are based in the <strong>United States<\/strong>, please call our Medical Information line at 1-888-FERRING (1-888-337-7464) to discuss your question. You can also email <a href=\"mailto:MedQueriesUS@ferring.com\">MedQueriesUS@ferring.com<\/a>.<\/p>\n<p>If you are based in <strong>Canada<\/strong>, please contact <a href=\"mailto:info@ferring.com\">info@ferring.com<\/a> with your question and share your contact telephone number so that a member of the local team can contact you.<\/p>\n<p><strong><em><u><br \/>\nEurope<br \/>\n<\/u><\/em><\/strong>If you are based in <strong>Europe<\/strong>, please contact <a href=\"mailto:info@ferring.com\">info@ferring.com<\/a> with your question and share your contact telephone number so that a member of your local team can contact you.<\/p>\n<p><strong><em><u><br \/>\nAsia-Pacific<br \/>\n<\/u><\/em><\/strong>If you are based in <strong>India<\/strong>, please contact <a href=\"mailto:medicaldesk.india@ferring.com\">medicaldesk.india@ferring.com<\/a> and share your question and contact telephone number so that a member of the local team can contact you.<\/p>\n<p>If you are based in <strong>other locations in Asia-Pacific<\/strong>, please contact <a href=\"mailto:info@ferring.com\">info@ferring.com<\/a> with your question and share your contact telephone number so that a member of the local team can contact you.<\/p>\n<p><strong><em><u><br \/>\nLatin America<br \/>\n<\/u><\/em><\/strong>If you are based in <strong>Latin America<\/strong>, please contact <a href=\"mailto:info@ferring.com\">info@ferring.com<\/a> with your question and share your contact telephone number so that a member of the local team can contact you.<\/p>\n<p><strong><em><br \/>\n<\/em><\/strong><strong><em><u>Middle East and Africa<br \/>\n<\/u><\/em><\/strong>If you are based in the <strong>Middle East or Africa<\/strong>, please email <a href=\"mailto:info@ferring.com\">info@ferring.com<\/a> with your question and share your contact telephone number so that a member of the local team can contact you.<\/p>\n[\/spb_boxed_content] [spb_blank_spacer height=”30px” width=”1\/1″ el_position=”first last”] [spb_button button_text=”READ MORE PRESS RELEASES” button_size=”standard” button_colour=”accent” button_type=”standard” rounded=”no” button_dropshadow=”no” button_link=”\/media\/press-releases\/” button_target=”_self” align=”center” animation=”none” animation_delay=”0″ width=”1\/1″ el_position=”first last”]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[spb_boxed_content type=”coloured” box_link_target=”_self” padding_vertical=”0″ padding_horizontal=”0″ width=”1\/1″ el_position=”first last”] Ferring Statement on Minirin\u00ae\/Octostim\u00ae\/DDAVP\u00ae\/Stimate\u00ae (desmopressin) Nasal Spray [\/spb_boxed_content] [spb_blank_spacer height=”30px” width=”1\/1″ el_position=”first last”] [spb_boxed_content type=”coloured” box_link_target=”_self” padding_vertical=”0″ padding_horizontal=”0″ width=”1\/1″ el_position=”first last”] Saint-Prex, Switzerland \u2013 21 June, 2022 \u2013 Minirin\u00ae (desmopressin) Nasal Spray 0.1 mg\/ml room temperature stable (RTS)\/ Octostim\u00ae (desmopressin) Nasal Spray 1.5 mg\/ml\/ DDAVP\u00ae (desmopressin acetate, 10 mcg\/0.1 mL)\/ Stimate\u00ae (desmopressin […]<\/p>\n","protected":false},"author":4746,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1476],"tags":[],"class_list":["post-26041","post","type-post","status-publish","format-standard","hentry","category-statement-2022"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.3 (Yoast SEO v23.3) - 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