{"id":1400,"date":"2015-04-08T13:43:41","date_gmt":"2015-04-08T13:43:41","guid":{"rendered":"http:\/\/www.wi.rwth-aachen.de\/SmartMedCN\/?p=1400"},"modified":"2015-04-08T13:43:41","modified_gmt":"2015-04-08T13:43:41","slug":"fda-is-sued-by-otsuka-for-unlawfully-widening-the-market-for-abilify","status":"publish","type":"post","link":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/2015\/04\/08\/fda-is-sued-by-otsuka-for-unlawfully-widening-the-market-for-abilify\/","title":{"rendered":"FDA is Sued by Otsuka for \u2018Unlawfully\u2019 Widening the Market for Abilify"},"content":{"rendered":"

It\u2019s not every day that a drug maker complains the FDA widened a market for one of its drugs.\u00a0But this is what Ostuka Pharmaceuticals is doing in a lawsuit claiming the agency illegally broadened the indication for its best-selling Abilify antipsychotic, unfairly opening the door to generic competition in the process. And the outcome could allow generic versions of Abilify on the market much sooner than Otsuka had expected, affecting the fortunes of the Japanese drug maker, which is trying to expand its presence in the lucrative U.S. market. (Source: WSJ Pharmalot)<\/strong><\/p>\n

FDA\u644a\u4e0a\u5927\u4e8b\u4e86 \u65e5\u672cOtsuka\u8d77\u8bc9FDA\u6ee5\u7528\u76d1\u7ba1\u6743<\/h3>\n

\u6765\u6e90\uff1a\u751f\u7269\u8c37<\/p>\n

\u6838\u5fc3\u63d0\u793a\uff1a\u65e5\u672cOtsuka Pharmaceuticals\u516c\u53f8\u6700\u8fd1\u5728\u7f8e\u56fd\u8054\u90a6\u5730\u65b9\u6cd5\u9662\u8d77\u8bc9FDA\u6ee5\u7528\u76d1\u7ba1\u6743\uff0c\u635f\u5bb3\u4e86\u65d7\u4e0bAbilify\u7684\u5e02\u573a\u6743\u76ca\uff0c\u6700\u7ec8\u51b3\u5b9a\u548cFDA\u5bf9\u7c3f\u516c\u5802\u3002\u4e00\u822c\u800c\u8a00\uff0c\u5bf9\u4e8e\u751f\u7269\u533b\u836f\u516c\u53f8\u6765\u8bf4\uff0c\u5f53\u4ed6\u4eec\u7684\u836f\u7269\u4e0a\u5e02\u65f6\u5019\uff0c\u4e3a\u4e86\u6269\u5927\u9500\u91cf\u552f\u6050FDA\u6240\u6279\u51c6\u7684\u9002\u5e94\u75c7\u4e0d\u591f\u591a\uff0c\u8986\u76d6\u7684\u60a3\u8005\u7fa4\u4f53\u4e0d\u591f\u5e7f\u3002\u800c\u5728\u8fd9\u8d77\u6848\u4ef6\u4e2d\uff0cOtsuka Pharmaceuticals\u5374\u5e0c\u671b\u8fd9\u4e00\u836f\u7269\u7684\u9002\u7528\u75c7\u8303\u56f4\u5c3d\u53ef\u80fd\u9650\u5236\u5728\u4e00\u5b9a\u4eba\u7fa4\u4e2d\u3002Otsuka\u516c\u53f8\u5f00\u53d1\u7684Abilify\u6b64\u524d\u88ab\u6279\u51c6\u5e94\u7528\u4e8e\u6cbb\u7597\u59a5\u745e\u75c7\u3001\u8e81\u90c1\u75c7\u4ee5\u53ca\u7cbe\u795e\u5206\u88c2\u75c7\u3002\u76f8\u5173\u8d44\u6599\u663e\u793a\uff0cAbilify\u5c06\u4e8e\u4eca\u5e74\u56db\u670820\u65e5\u5931\u53bb\u4e13\u5229\u4fdd\u62a4\uff0c\u5e76\u5c06\u9762\u4e34\u4eff\u5236\u836f\u7684\u6311\u6218\u3002Otsuka\u516c\u53f8\u8868\u793a\u7531\u4e8eAbilify\u6b64\u524d\u662f\u4f5c\u4e3a\u7f55\u89c1\u75be\u75c5\u59a5\u745e\u75c7\u7684\u6cbb\u7597\u65b9\u6848\u7533\u8bf7\u4e0a\u5e02\u7684\uff0c\u56e0\u6b64Abilify\u5e94\u5f53\u4eab\u53d7\u5b64\u513f\u836f\u6240\u5177\u6709\u7684\u4e00\u5207\u4f18\u60e0\u63aa\u65bd\u3002\u8fd9\u5c31\u610f\u5473\u7740Abilify\u7684\u6392\u4ed6\u6027\u7ecf\u8425\u6743\u5c06\u518d\u5ef6\u957f7\u5e74\u4e4b\u4e45\u3002\u7136\u800c\uff0cFDA\u5374\u4e8e\u6700\u8fd1\u5c06Abilify\u7684\u9002\u7528\u8303\u56f4\u6269\u5927\u81f3\u56fe\u96f7\u7279\u7efc\u5408\u5f81\u3002\u6839\u636e\u76f8\u5173\u89c4\u5b9a\uff0c\u8fd9\u4e5f\u610f\u5473\u7740Abilify\u5c06\u65e0\u6cd5\u83b7\u5f97\u5ef6\u957f\u7684\u6392\u4ed6\u6027\u7ecf\u8425\u6743\u3002<\/p>\n

[hide for= “!logged”]<\/p>\n

\u81ea\u53e4\u4ee5\u6765\uff0c\u6c11\u544a\u5b98\u5c31\u662f\u96be\u4e8e\u4e0a\u9752\u5929\u3002\u8bb8\u591a\u4eba\u9762\u5bf9\u201c\u6709\u5173\u90e8\u95e8\u201d\u6ee5\u7528\u6743\u529b\u65f6\u90fd\u9009\u62e9\u4e86\u606f\u4e8b\u5b81\u4eba\uff0c\u6b63\u6240\u8c13\u662f\u505a\u4eba\u7559\u4e00\u7ebf\uff0c\u65e5\u540e\u597d\u76f8\u89c1\u3002\u800cFDA\u4f5c\u4e3a\u5728\u7f8e\u56fd\u751f\u7269\u533b\u836f\u9886\u57df\u8d1f\u8d23\u5ba1\u6279\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u548c\u4e0a\u5e02\u4e8b\u5b9c\u7684\u6700\u9ad8\u673a\u6784\uff0c\u5728\u4f17\u591a\u751f\u7269\u533b\u836f\u516c\u53f8\u770b\u6765\u53ef\u8c13\u662f\u6267\u638c\u4e86\u751f\u6740\u5927\u6743\u3002<\/p>\n

\u4e0d\u8fc7\uff0c\u8f83\u771f\u7684\u65e5\u672c\u4eba\u6700\u8fd1\u8fd8\u771f\u5c31\u628aFDA\u544a\u4e0a\u4e86\u6cd5\u5ead\u3002\u6d88\u606f\u663e\u793a\uff0c\u65e5\u672cOtsuka Pharmaceuticals\u516c\u53f8\u6700\u8fd1\u5728\u7f8e\u56fd\u8054\u90a6\u5730\u65b9\u6cd5\u9662\u8d77\u8bc9FDA\u6ee5\u7528\u76d1\u7ba1\u6743\uff0c\u635f\u5bb3\u4e86\u65d7\u4e0bAbilify\u7684\u5e02\u573a\u6743\u76ca\uff0c\u6700\u7ec8\u51b3\u5b9a\u548cFDA\u5bf9\u7c3f\u516c\u5802\u3002<\/p>\n

\u8bf4\u6765\u8fd9\u4e00\u6848\u4ef6\u4e5f\u591f\u79bb\u5947\uff0c\u4e00\u822c\u800c\u8a00\uff0c\u5bf9\u4e8e\u751f\u7269\u533b\u836f\u516c\u53f8\u6765\u8bf4\uff0c\u5f53\u4ed6\u4eec\u7684\u836f\u7269\u4e0a\u5e02\u65f6\u5019\uff0c\u4e3a\u4e86\u6269\u5927\u9500\u91cf\u552f\u6050FDA\u6240\u6279\u51c6\u7684\u9002\u5e94\u75c7\u4e0d\u591f\u591a\uff0c\u8986\u76d6\u7684\u60a3\u8005\u7fa4\u4f53\u4e0d\u591f\u5e7f\u3002\u800c\u5728\u8fd9\u8d77\u6848\u4ef6\u4e2d\uff0cOtsuka Pharmaceuticals\u5374\u5e0c\u671b\u8fd9\u4e00\u836f\u7269\u7684\u9002\u7528\u75c7\u8303\u56f4\u5c3d\u53ef\u80fd\u9650\u5236\u5728\u4e00\u5b9a\u4eba\u7fa4\u4e2d\u3002<\/p>\n

\u539f\u6765\uff0c\u6b64\u6b21\u53cc\u65b9\u9762\u4e34\u7684\u7126\u70b9\u5728\u4e8eOtsuka\u516c\u53f8\u5f00\u53d1\u7684Abilify\u6b64\u524d\u88ab\u6279\u51c6\u5e94\u7528\u4e8e\u6cbb\u7597\u59a5\u745e\u75c7\u3001\u8e81\u90c1\u75c7\u4ee5\u53ca\u7cbe\u795e\u5206\u88c2\u75c7\u3002\u8fd9\u79cd\u836f\u7269\u5df2\u7ecf\u4e0a\u5e02\uff0c\u5c31\u4e3aOtsuka\u516c\u53f8\u5e26\u6765\u8d85\u8fc7650\u4e07\u7f8e\u5143\u7684\u6536\u5165\u3002\u4e0d\u8fc7\u76f8\u5173\u8d44\u6599\u663e\u793a\uff0cAbilify\u5c06\u4e8e\u4eca\u5e74\u56db\u670820\u65e5\u5931\u53bb\u4e13\u5229\u4fdd\u62a4\uff0c\u5e76\u5c06\u9762\u4e34\u4eff\u5236\u836f\u7684\u6311\u6218\u3002\u53ef\u4ee5\u9884\u60f3\uff0cAbilify\u7684\u9500\u552e\u989d\u5fc5\u5c06\u5927\u53d7\u5f71\u54cd\u3002<\/p>\n

\u4e0d\u8fc7\uff0cOtsuka\u516c\u53f8\u5e76\u4e0d\u5e0c\u671b\u8f7b\u6613\u653e\u5f03\u516c\u53f8\u7684\u8fd9\u68f5\u6447\u94b1\u6811\u3002Otsuka\u516c\u53f8\u8868\u793a\u7531\u4e8eAbilify\u6b64\u524d\u662f\u4f5c\u4e3a\u7f55\u89c1\u75be\u75c5\u59a5\u745e\u75c7\u7684\u6cbb\u7597\u65b9\u6848\u7533\u8bf7\u4e0a\u5e02\u7684\uff0c\u56e0\u6b64Abilify\u5e94\u5f53\u4eab\u53d7\u5b64\u513f\u836f\u6240\u5177\u6709\u7684\u4e00\u5207\u4f18\u60e0\u63aa\u65bd\u3002\u8fd9\u5c31\u610f\u5473\u7740Abilify\u7684\u6392\u4ed6\u6027\u7ecf\u8425\u6743\u5c06\u518d\u5ef6\u957f7\u5e74\u4e4b\u4e45\u3002<\/p>\n

\u7136\u800c\uff0cFDA\u5374\u4e8e\u6700\u8fd1\u5c06Abilify\u7684\u9002\u7528\u8303\u56f4\u6269\u5927\u81f3\u56fe\u96f7\u7279\u7efc\u5408\u5f81(Tourette syndrome \uff0cTS\u662f\u4e00\u79cd\u76f8\u5bf9\u666e\u901a\u7684\u795e\u7ecf\u7d0a\u4e71\uff0c\u7279\u5f81\u662f\u65e0\u610f\u8bc6\u5730\u5feb\u901f\u62bd\u6410\uff0c\u7a81\u7136\u79fb\u52a8\uff0c\u6216\u8005\u53d1\u51fa\u58f0\u97f3\uff0c\u5e76\u4e14\u4ee5\u76f8\u540c\u7684\u65b9\u5f0f\u91cd\u590d)\u7684\u6cbb\u7597\uff0c\u6839\u636e\u76f8\u5173\u89c4\u5b9a\uff0c\u8fd9\u4e5f\u610f\u5473\u7740Abilify\u5c06\u65e0\u6cd5\u83b7\u5f97\u5ef6\u957f\u7684\u6392\u4ed6\u6027\u7ecf\u8425\u6743\u3002<\/p>\n

Otsuka\u516c\u53f8\u8d77\u8bc9FDA\u5728\u7f3a\u4e4f\u76f8\u5173\u4e34\u5e8a\u6570\u636e\u7684\u57fa\u7840\u4e0a\uff0c\u672a\u80fd\u5145\u5206\u8003\u8651\u5230Abilify\u5bf9\u56fe\u96f7\u7279\u7efc\u5408\u5f81\u60a3\u8005\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7b49\u65b9\u9762\u5c31\u505a\u51fa\u4e86\u8fd9\u4e00\u51b3\u5b9a\uff0c\u6d89\u53ca\u6ee5\u7528\u5176\u5ba1\u6279\u6743\u5229\uff0c\u56e0\u800c\u8bf7\u6c42\u6cd5\u9662\u9a73\u56deFDA\u7684\u8fd9\u4e00\u51b3\u5b9a\u3002<\/p>\n

Otsuka\u516c\u53f8\u4e0eFDA\u7684\u8fd9\u4e00\u4e89\u6267\u76ee\u524d\u4e3a\u6b62\u5c1a\u5c5e\u7f55\u89c1\u3002\u4e0d\u8fc7\uff0c\u65e0\u8bba\u7ed3\u679c\u5982\u4f55\uff0c\u5c0f\u7f16\u7a83\u4ee5\u4e3a\u8fd9\u6837\u7684\u505a\u6cd5\u5fc5\u5c06\u6709\u5229\u4e8e\u89c4\u8303\u751f\u7269\u533b\u836f\u4f01\u4e1a\u4ee5\u53ca\u533b\u836f\u7ba1\u7406\u673a\u6784\u53cc\u65b9\u7684\u884c\u4e3a\u89c4\u8303\u3002\u8fd9\u79cd\u4e0d\u754f\u516c\u5171\u6743\u529b\uff0c\u6562\u4e8e\u4e00\u5207\u4ece\u6cd5\u5f8b\u89d2\u5ea6\u51fa\u53d1\u548c\u884c\u653f\u90e8\u95e8\u201c\u53eb\u677f\u201d\u7684\u7cbe\u795e\u503c\u5f97\u56fd\u5185\u7684\u7ba1\u7406\u673a\u6784\u548c\u533b\u836f\u884c\u4e1a\u4ece\u4e1a\u8005\u5b66\u4e60\u3002<\/p>\n

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

It\u2019s not every day that a drug maker complains the FDA widened a market for one of its drugs.\u00a0But this is what Ostuka Pharmaceuticals is doing in a lawsuit claiming […]<\/p>\n","protected":false},"author":1001,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"c2c_always_allow_admin_comments":false,"footnotes":""},"categories":[5],"tags":[10,17],"class_list":["post-1400","post","type-post","status-publish","format-standard","hentry","category-pharmaceutical-company-news","tag-dispute","tag-government-supervision"],"_links":{"self":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/1400","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/users\/1001"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/comments?post=1400"}],"version-history":[{"count":0,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/1400\/revisions"}],"wp:attachment":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/media?parent=1400"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/categories?post=1400"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/tags?post=1400"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}