{"id":52625,"date":"2018-09-29T01:00:00","date_gmt":"2018-09-30T01:35:55","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/fda%e6%96%b0%e8%8d%af%e9%80%9f%e9%80%92%ef%bc%9a%e9%98%bf%e7%b1%b3%e5%8d%a1%e6%98%9f%e8%84%82%e8%b4%a8%e4%bd%93%e5%90%b8%e5%85%a5%e6%b7%b7%e6%82%ac%e6%b6%b2%e6%98%a8%e6%97%a5%e8%8e%b7%e6%89%b9\/"},"modified":"2018-09-30T09:36:01","modified_gmt":"2018-09-30T01:36:01","slug":"fda%e6%96%b0%e8%8d%af%e9%80%9f%e9%80%92%ef%bc%9a%e9%98%bf%e7%b1%b3%e5%8d%a1%e6%98%9f%e8%84%82%e8%b4%a8%e4%bd%93%e5%90%b8%e5%85%a5%e6%b7%b7%e6%82%ac%e6%b6%b2%e6%98%a8%e6%97%a5%e8%8e%b7%e6%89%b9","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/52625\/","title":{"rendered":"FDA\u65b0\u836f\u901f\u9012\uff1a\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u6df7\u60ac\u6db2\u6628\u65e5\u83b7\u6279"},"content":{"rendered":"
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<\/p>\n

For Immediate Release<\/h2>\n

September 28, 2018<\/span><\/p>\n


<\/p>\n

Release<\/h2>\n

The U.S. Food and Drug Administration today approved a new drug, Arikayce (amikacin liposome inhalation suspension)<\/span>, for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease).\uff08\u6cbb\u7597\u7531\u9e1f\u578b\u5206\u679d\u6746\u83cc\uff08MAC\uff09\u5f15\u8d77\u7684\u80ba\u90e8\u75be\u75c5\uff0c\u8be5\u75be\u75c5\u60a3\u8005\u4eba\u6570\u6709\u9650\uff0c\u7f55\u89c1\u75c5\u836f\u7269\uff09<\/span><\/p>\n

MAC is a type of nontuberculous mycobacteria (NTM) commonly found in water and soil. Symptoms of disease in patients with MAC include persistent cough, fatigue, weight loss, night sweats, and occasionally shortness of breath and coughing up of blood.<\/p>\n

“As bacteria continue to grow impervious to currently available antibiotics, we need to encourage the development of drugs that can treat resistant infections. That means utilizing novel tools intended to streamline development and encourage investment into these important endeavors,” said FDA Commissioner Scott Gottlieb, M.D. “This approval is the first time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, and it marks an important policy milestone. This pathway, advanced by Congress, aims to spur development of drugs targeting infections that lack effective therapies. We\u2019re seeing a lot of early interest among sponsors in using this new pathway, and it\u2019s our hope that it\u2019ll spur more development and approval of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs.”<\/p>\n

\"FDA\u65b0\u836f\u901f\u9012\uff1a\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u6df7\u60ac\u6db2\u6628\u65e5\u83b7\u6279\"<\/p>\n

https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm622048.htm<\/span>
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\u9644\uff1a<\/strong><\/span><\/p>\n

\u622a\u6b629\u670829\u65e5\uff0cFDA\u6279\u51c6\u4e8642\u6b3e\u836f\u7269\u3002<\/strong><\/span><\/p>\n


<\/strong><\/span><\/p>\n

\u5176\u4e2dFDA\u6279\u51c634\u6b3e\u65b0\u836f\uff0c\u622a\u6b622018\u5e748\u670830\u65e5<\/p>\n

Novel Drug Approvals for 2018\uff0cUpdate to 8\/30\/2018<\/span><\/h2>\n
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\"FDA\u65b0\u836f\u901f\u9012\uff1a\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u6df7\u60ac\u6db2\u6628\u65e5\u83b7\u6279\"<\/p>\n<\/section>\n

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\"FDA\u65b0\u836f\u901f\u9012\uff1a\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u6df7\u60ac\u6db2\u6628\u65e5\u83b7\u6279\"<\/p>\n<\/section>\n

\"FDA\u65b0\u836f\u901f\u9012\uff1a\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u6df7\u60ac\u6db2\u6628\u65e5\u83b7\u6279\"<\/p>\n

\"FDA\u65b0\u836f\u901f\u9012\uff1a\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u6df7\u60ac\u6db2\u6628\u65e5\u83b7\u6279\"<\/p>\n

\"FDA\u65b0\u836f\u901f\u9012\uff1a\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u6df7\u60ac\u6db2\u6628\u65e5\u83b7\u6279\"<\/p>\n

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* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug\u2019s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug\u2019s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.\uff08FDA\u662f\u52a8\u6001\u53ca\u65f6\u66f4\u65b0\u65b0\u5206\u5b50\u5b9e\u4f53\u6216\u8005\u751f\u7269\u836f\u3001\u75ab\u82d7\u7b49\u83b7\u6279\u60c5\u51b5\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n


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<\/span>
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\u53c2\u8003\uff1a<\/span><\/strong><\/span><\/p>\n

NMPA\/CDE\uff1b<\/span><\/h1>\n

\u836f\u878d\u6570\u636e\uff0cPharnex  Datamonitor;<\/span><\/p>\n

\u76f8\u5173\u516c\u53f8\u516c\u5f00\u62ab\u9732\u7b49\u3002<\/span><\/p>\n


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\"FDA\u65b0\u836f\u901f\u9012\uff1a\u963f\u7c73\u5361\u661f\u8102\u8d28\u4f53\u5438\u5165\u6df7\u60ac\u6db2\u6628\u65e5\u83b7\u6279\"<\/span><\/p>\n

\u836f\u878d\u5708\u4e3a\u836f\u7269\u7b80\u8baf\u5408\u4f5c\u5e73\u53f0.<\/span>
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<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

For Immediate Release September 28, 2018 Release The U. […]<\/p>\n","protected":false},"author":1,"featured_media":52626,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52625"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=52625"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52625\/revisions"}],"predecessor-version":[{"id":52634,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/52625\/revisions\/52634"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/52626"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=52625"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=52625"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=52625"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}