{"id":7413,"date":"2016-07-22T07:24:12","date_gmt":"2016-07-22T07:24:12","guid":{"rendered":"https:\/\/www.nicox.com\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/"},"modified":"2016-07-22T07:24:12","modified_gmt":"2016-07-22T07:24:12","slug":"communique-de-presse-relatif-au-latanoprostene-bunod-2","status":"publish","type":"post","link":"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/","title":{"rendered":"Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod"},"content":{"rendered":"<p><strong>Nicox S.A.<\/strong> (Euronext Paris : FR0013018124, COX, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, a \u00e9t\u00e9 inform\u00e9e par son partenaire Bausch + Lomb (filiale de Valeant Pharmaceuticals International, Inc.) de la r\u00e9ception d&rsquo;une lettre de r\u00e9ponse (<em>Complete Response Letter<\/em>) de la <em>Food and Drug Administration<\/em> am\u00e9ricaine (FDA) pour le latanoprost\u00e8ne bunod en cons\u00e9quence de laquelle Valeant a publi\u00e9 le communiqu\u00e9 de presse ci-joint aujourd&rsquo;hui dont une traduction libre du texte est copi\u00e9e ci-dessous :<\/p>\n<p style=\"text-align: center;\"><strong>VALEANT PHARMACEUTICALS RE\u00c7OIT UNE LETTRE DE R\u00c9PONSE <\/strong><br \/><strong>(COMPLETE RESPONSE LETTER) DE LA FDA<\/strong><\/p>\n<p style=\"text-align: center;\"><em>Aucun commentaire concernant la s\u00e9curit\u00e9 ou l\u2019efficacit\u00e9, ni de demande d\u2019\u00e9tudes cliniques<\/em><br \/><em> suppl\u00e9mentaires pour l\u2019approbation du latanoprost\u00e8ne bunod<\/em><\/p>\n<p style=\"text-align: center;\"><em>La lettre de la FDA, relative aux Bonnes Pratiques de Fabrication Actuelles (CGMP) <\/em><br \/><em>concerne le site de fabrication de Bausch + Lomb<\/em><\/p>\n<p>LAVAL, QUEBEC\u2013 22 juillet 2016 &#8211; Valeant Pharmaceuticals International, Inc. (NYSE : VRX et TSX: VRX) annonce aujourd\u2019hui avoir re\u00e7u une lettre de r\u00e9ponse de la FDA am\u00e9ricaine (<em>Food and Drug Administration<\/em>) relative au dossier de <em>New Drug Application<\/em> (NDA) pour la solution ophtalmique de latanoprost\u00e8ne bunod, 0,024%, un collyre en monoth\u00e9rapie visant \u00e0 abaisser la pression intraoculaire chez les patients atteints de glaucome \u00e0 angle ouvert ou d\u2019hypertension oculaire. Les commentaires de la FDA concernent une inspection BPFA (Bonnes Pratiques de Fabrication Actuelles, <em>Current Good Manufacturing Practice<\/em> CGMP) de l\u2019usine de fabrication de Bausch + Lomb \u00e0 Tampa en Floride, o\u00f9 certaines d\u00e9ficiences ont \u00e9t\u00e9 identifi\u00e9es par la FDA. La lettre de la FDA ne fait \u00e9tat d\u2019aucun commentaire quant \u00e0 l\u2019efficacit\u00e9 ou \u00e0 la s\u00e9curit\u00e9 de la solution ophtalmique de latanoprost\u00e8ne bunod, 0,024% et aucune \u00e9tude clinique suppl\u00e9mentaire n\u2019est requise pour l\u2019autorisation de mise sur le march\u00e9.<\/p>\n<p>Valeant entend rencontrer la FDA au plus t\u00f4t afin de r\u00e9soudre la situation en r\u00e9pondant \u00e0 ces commentaires.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Nicox S.A. (Euronext Paris : FR0013018124, COX, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, a \u00e9t\u00e9 inform\u00e9e par son partenaire Bausch + Lomb (filiale de Valeant Pharmaceuticals International, Inc.) de la r\u00e9ception d&rsquo;une lettre de r\u00e9ponse (Complete Response Letter) de la Food and Drug Administration am\u00e9ricaine (FDA) pour le latanoprost\u00e8ne bunod en cons\u00e9quence de laquelle [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[32,16],"tags":[],"class_list":["post-7413","post","type-post","status-publish","format-standard","hentry","category-actualites","category-actualites-et-media"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod - Nicox<\/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.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod - Nicox\" \/>\n<meta property=\"og:description\" content=\"Nicox S.A. (Euronext Paris : FR0013018124, COX, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, a \u00e9t\u00e9 inform\u00e9e par son partenaire Bausch + Lomb (filiale de Valeant Pharmaceuticals International, Inc.) de la r\u00e9ception d&rsquo;une lettre de r\u00e9ponse (Complete Response Letter) de la Food and Drug Administration am\u00e9ricaine (FDA) pour le latanoprost\u00e8ne bunod en cons\u00e9quence de laquelle [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/\" \/>\n<meta property=\"og:site_name\" content=\"Nicox\" \/>\n<meta property=\"article:published_time\" content=\"2016-07-22T07:24:12+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/communique-de-presse-relatif-au-latanoprostene-bunod-2\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/communique-de-presse-relatif-au-latanoprostene-bunod-2\\\/\"},\"author\":{\"name\":\"\",\"@id\":\"\"},\"headline\":\"Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod\",\"datePublished\":\"2016-07-22T07:24:12+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/communique-de-presse-relatif-au-latanoprostene-bunod-2\\\/\"},\"wordCount\":327,\"publisher\":{\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/#organization\"},\"articleSection\":[\"Actualit\u00e9s\",\"Actualit\u00e9s et M\u00e9dia\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/communique-de-presse-relatif-au-latanoprostene-bunod-2\\\/\",\"url\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/communique-de-presse-relatif-au-latanoprostene-bunod-2\\\/\",\"name\":\"Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod - Nicox\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/#website\"},\"datePublished\":\"2016-07-22T07:24:12+00:00\",\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.nicox.com\\\/fr\\\/communique-de-presse-relatif-au-latanoprostene-bunod-2\\\/\"]}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/#website\",\"url\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/\",\"name\":\"Nicox\",\"description\":\"Visible Science\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/#organization\",\"name\":\"Nicox\",\"url\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"Nicox\"},\"image\":{\"@id\":\"https:\\\/\\\/www.nicox.com\\\/fr\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod - Nicox","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/","og_locale":"fr_FR","og_type":"article","og_title":"Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod - Nicox","og_description":"Nicox S.A. (Euronext Paris : FR0013018124, COX, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, a \u00e9t\u00e9 inform\u00e9e par son partenaire Bausch + Lomb (filiale de Valeant Pharmaceuticals International, Inc.) de la r\u00e9ception d&rsquo;une lettre de r\u00e9ponse (Complete Response Letter) de la Food and Drug Administration am\u00e9ricaine (FDA) pour le latanoprost\u00e8ne bunod en cons\u00e9quence de laquelle [&hellip;]","og_url":"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/","og_site_name":"Nicox","article_published_time":"2016-07-22T07:24:12+00:00","twitter_card":"summary_large_image","twitter_misc":{"\u00c9crit par":"","Dur\u00e9e de lecture estim\u00e9e":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/#article","isPartOf":{"@id":"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/"},"author":{"name":"","@id":""},"headline":"Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod","datePublished":"2016-07-22T07:24:12+00:00","mainEntityOfPage":{"@id":"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/"},"wordCount":327,"publisher":{"@id":"https:\/\/www.nicox.com\/fr\/#organization"},"articleSection":["Actualit\u00e9s","Actualit\u00e9s et M\u00e9dia"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/","url":"https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/","name":"Communiqu\u00e9 de Presse relatif au latanoprost\u00e8ne bunod - Nicox","isPartOf":{"@id":"https:\/\/www.nicox.com\/fr\/#website"},"datePublished":"2016-07-22T07:24:12+00:00","inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.nicox.com\/fr\/communique-de-presse-relatif-au-latanoprostene-bunod-2\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.nicox.com\/fr\/#website","url":"https:\/\/www.nicox.com\/fr\/","name":"Nicox","description":"Visible Science","publisher":{"@id":"https:\/\/www.nicox.com\/fr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.nicox.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/www.nicox.com\/fr\/#organization","name":"Nicox","url":"https:\/\/www.nicox.com\/fr\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/www.nicox.com\/fr\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Nicox"},"image":{"@id":"https:\/\/www.nicox.com\/fr\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":""}]}},"_links":{"self":[{"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/posts\/7413","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/comments?post=7413"}],"version-history":[{"count":0,"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/posts\/7413\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/media?parent=7413"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/categories?post=7413"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nicox.com\/fr\/wp-json\/wp\/v2\/tags?post=7413"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}