{"id":35736,"date":"2013-03-25T17:01:48","date_gmt":"2013-03-25T21:01:48","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=35736"},"modified":"2013-03-26T03:04:52","modified_gmt":"2013-03-26T07:04:52","slug":"once-again-fda-rejects-oral-treprostinil-for-pulmonary-arterial-hypertension","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/03\/25\/once-again-fda-rejects-oral-treprostinil-for-pulmonary-arterial-hypertension\/","title":{"rendered":"Once Again FDA Rejects Oral Treprostinil for Pulmonary Arterial Hypertension"},"content":{"rendered":"<p>For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil\u00a0for the treatment of pulmonary arterial hypertension (PAH). The manufacturer of the drug, United Therapeutics, said in\u00a0<a href=\"http:\/\/ir.unither.com\/releasedetail.cfm?ReleaseID=750550\">a press release<\/a>\u00a0that it planned to discuss the decision with the FDA.<\/p>\n<p>&#8220;We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner,&#8221; said the company&#8217;s chairman and CEO.<\/p>\n<p>Trepostinil is a\u00a0prostacyclin vasodilator that is already approved for the treatment of PAH in an\u00a0injectable form (Remodulin) and in an inhalable form (Tyvaso). The FDA initially rejected the NDA for the drug last October.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil\u00a0for the treatment of pulmonary arterial hypertension (PAH). The manufacturer of the drug, United Therapeutics, said in\u00a0a press release\u00a0that it planned to discuss the decision with the FDA. &#8220;We remain confident that oral treprostinil will [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[1746,196,1744,1745],"class_list":["post-35736","post","type-post","status-publish","format-standard","hentry","category-prevention","tag-complete-response-letter","tag-fda","tag-pulmonary-arterial-hypertension","tag-treprostinil"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/35736","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=35736"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/35736\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=35736"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=35736"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=35736"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}