{"id":9396,"date":"2016-07-26T10:24:55","date_gmt":"2016-07-26T10:24:55","guid":{"rendered":"http:\/\/revoscience.com\/en\/?p=9396"},"modified":"2016-07-26T10:24:55","modified_gmt":"2016-07-26T10:24:55","slug":"fda-denies-approval-of-valeants-eye-disease-drug","status":"publish","type":"post","link":"https:\/\/www.revoscience.com\/en\/fda-denies-approval-of-valeants-eye-disease-drug\/","title":{"rendered":"FDA Denies Approval of Valeant’s Eye Disease Drug"},"content":{"rendered":"
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\"ddd1604_valeant\"<\/a>Valeant Pharmaceuticals received a letter from the Food and Drug Administration (FDA) on Friday, which raised concerns about the company\u2019s experimental eye disease treatment, Vesneo.<\/span><\/p>\n

The complete response letter sent by the agency\u00a0explained<\/span><\/a>\u00a0it found \u2018deficiencies\u2019 in a Tampa, Florida-based Bausch + Lomb manufacturing facility during a standard Current Good Manufacturing Practice inspection.<\/span><\/p>\n

No specific safety or efficacy issues were mentioned in the note, but it does prolong Valeant\u2019s attempt at getting Vesneo regulatory approval.<\/span><\/p>\n

The drug is a latanoprostene bunod ophthalmic solution,\u00a0reported\u00a0FierceBiotech.<\/em><\/span><\/a>\u00a0Valeant submitted a new drug application (NDA) for it hoping to obtain a treatment indication for patients diagnosed with ocular hypertension or open angle glaucoma.<\/span><\/p>\n

The Canadian company is seeking a turnaround after a rough year where it came under fire for suspicious drug pricing policies and a relationship with a specialty pharmacy named Philidor.<\/span><\/p>\n

Valeant gained\u00a0regulatory approval<\/span><\/a>\u00a0for a psoriasis drug brodalumab earlier this week. The FDA\u2019s decision was initially inconclusive due to the drug\u2019s incomplete data\u00a0concerning<\/span><\/a>\u00a0the risk of suicide, but the organization granted approval as long as a risk program is installed to mitigate the danger of suicide from occurring.<\/span><\/p>\n

A statement posted by Valeant said it would meet with the FDA soon to resolve the matter related to Vesneo.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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

Valeant gained regulatory approval for a psoriasis drug brodalumab earlier this week. The FDA\u2019s decision was initially inconclusive due to the drug\u2019s incomplete data concerning the risk of suicide, but the organization granted approval as long as a risk program is installed to mitigate the danger of suicide from occurring.<\/p>\n","protected":false},"author":6,"featured_media":9397,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26,17],"tags":[],"class_list":["post-9396","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicine","category-research"],"featured_image_urls":{"full":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"thumbnail":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant-150x150.jpg",150,150,true],"medium":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant-300x200.jpg",300,200,true],"medium_large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"1536x1536":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"2048x2048":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"ultp_layout_landscape_large":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"ultp_layout_landscape":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"ultp_layout_portrait":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"ultp_layout_square":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"newspaper-x-single-post":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"newspaper-x-recent-post-big":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"newspaper-x-recent-post-list-image":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",95,63,false],"web-stories-poster-portrait":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",429,286,false],"web-stories-publisher-logo":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",96,64,false],"web-stories-thumbnail":["https:\/\/www.revoscience.com\/en\/wp-content\/uploads\/2016\/07\/ddd1604_valeant.jpg",150,100,false]},"author_info":{"info":["Amrita Tuladhar"]},"category_info":"Medicine<\/a> Research<\/a>","tag_info":"Research","comment_count":"0","_links":{"self":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts\/9396","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/comments?post=9396"}],"version-history":[{"count":0,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/posts\/9396\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/media\/9397"}],"wp:attachment":[{"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/media?parent=9396"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/categories?post=9396"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.revoscience.com\/en\/wp-json\/wp\/v2\/tags?post=9396"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}