{"id":41872,"date":"2018-09-16T01:00:00","date_gmt":"2018-09-17T06:56:32","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e4%b8%ad%e5%9b%bd%e8%8d%af%e4%bc%81%e8%bf%84%e4%bb%8a%e8%8e%b7%e5%be%97%e7%9a%8450%e4%b8%aaanda\/"},"modified":"2018-09-17T14:56:37","modified_gmt":"2018-09-17T06:56:37","slug":"%e4%b8%ad%e5%9b%bd%e8%8d%af%e4%bc%81%e8%bf%84%e4%bb%8a%e8%8e%b7%e5%be%97%e7%9a%8450%e4%b8%aaanda","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/41872\/","title":{"rendered":"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p><span style=\"color: rgb(2, 30, 170);\"><strong><span style=\"font-size: 18px;\">\u836f\u878d\u5708\u5fae\u4fe1\u53f7<\/span><\/strong><\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u8d8a\u6765\u8d8a\u591a\u7684\u5236\u836f\u4f01\u4e1a\uff0c\u7acb\u8db3\u56fd\u5185\u5e02\u573a\uff0c\u79ef\u6781\u5f00\u62d3\u7f8e\u56fd\u548c\u6b27\u6d32\u5e02\u573a\uff01\u6279\u6587\u6570\u4e0d\u65ad\u7d2f\u79ef\uff0c\u4f46\u662f\u5236\u5242\u8425\u6536\u9664\u6052\u745e\u533b\u836f\u3001\u534e\u6d77\u836f\u4e1a\u3001\u5357\u901a\u8054\u4e9a\u3001\u4eba\u798f\u533b\u836f\u3001\u9f50\u9c81\u5236\u836f\u4ee5\u5916\u7684\u4f01\u4e1a\uff0c\u5bf9\u7f8e\u51fa\u53e3\u4e1a\u7ee9\u8f83\u5c0f\u3002\u636e\u4e2d\u56fd\u533b\u836f\u4fdd\u5065\u54c1\u8fdb\u51fa\u53e3\u5546\u4f1a\uff1a2018\u5e74\u4e00\u5b63\u5ea6\uff0c\u4e2d\u56fd\u5bf9\u7f8e\u56fd\u5316\u836f\u5236\u5242\u51fa\u53e3\u989d\u8d85\u8fc79000\u4e07\u7f8e\u5143\uff0c\u540c\u6bd4\u589e\u957f18.8%\u3002\u4e0a\u8ff05\u5bb6\u4f4d\u5c45\u51fa\u53e3\u524d\u5217\uff0c\u5360\u5236\u5242\u603b\u51fa\u53e3\u989d\u768467%\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;color: rgb(217, 33, 66);\">\u4e2d\u56fd\u836f\u4f012018\u81f3\u4eca\u5e74\u83b7\u5f97\u7684ANDA\uff0c\u622a\u6b6209\/12\/2018<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><img class=\"\"     style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 677px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/10-1537167393.jpeg\" alt=\"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA\" title=\"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA\"  \/><\/p>\n<p><img class=\"\"     style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 677px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/8-1537167394.jpeg\" alt=\"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA\" title=\"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA\"  \/><\/p>\n<p><img class=\"\"     style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 677px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/4-1537167395.jpeg\" alt=\"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA\" title=\"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA\"  \/><\/p>\n<p><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 677px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/9-1537167396.jpeg\" alt=\"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA\" title=\"\u4e2d\u56fd\u836f\u4f01\u8fc4\u4eca\u83b7\u5f97\u768450\u4e2aANDA\"  \/><\/p>\n<p><br  \/><\/p>\n<p><span style=\"font-size: 16px;\">\u6ce8\uff1a<\/span><\/p>\n<p><span style=\"font-size: 16px;\">1.&nbsp;Aucta Pharmaceuticals, Inc. (AUCTA\uff0c\u5965\u79d1\u8fbe\u5728\u62c9\u4e01\u8bed\u4e2d\u7684\u610f\u601d\u662f\u201c \u6539\u8fdb\u7684\u201d\uff0c\u201c\u66f4\u597d\u7684\u201d)\uff1b<\/span><\/p>\n<p><span style=\"font-size: 16px;\">2.&nbsp;SCIECURE PHARMA INC\uff0c\u4e16\u6865\u751f\u7269\uff0c\u5e03\u5730\u5948\u5fb7\u80f6\u56ca3mg\u4e8e2017\u5e7409\u670828\u65e5\u83b7\u7f8e\u56fdFDA\u4e0a\u5e02\u8bb8\u53ef\uff08ANDA\uff09\uff0c\u4e16\u6865\u751f\u7269\u7b2c\u4e00\u4e2a\u83b7\u5f97ANDA\u7684\u4ea7\u54c1\uff1b<\/span><\/p>\n<p><span style=\"font-size: 16px;\">3.&nbsp;HONG KONG\uff0c\u516c\u53f8\u6bcd\u516c\u53f8\u4e3a\u5357\u4eac\u5065\u53cb\uff0c\u540d\u5b57\u6bd4\u8f83\u9690\u853d\uff1b<\/span><\/p>\n<p><span style=\"font-size: 16px;\">4.&nbsp;AIPING PHARM INC\uff0c\u7231\u5e73\u5236\u836f\uff0c\u4e0d\u8ba4\u771f\u8fd8\u770b\u4e0d\u51fa\u662f\u56fd\u5185\u4f01\u4e1a\u2026,\u5b89\u58eb\u5236\u836fA&amp;Z Pharmaceutical\uff0c\u96b6\u5c5e\u4e8e\u767e\u6d0b\u533b\u836f\u96c6\u56e2\uff1b<\/span><\/p>\n<p><span style=\"font-size: 16px;\">5.&nbsp;TWI PHARMS\u65e9\u524d\u88abPAR\u6536\u8d2d\uff0c\u5e76\u4e0d\u662f\u6211\u56fd\u53f0\u6e7e\u5730\u533a\u516c\u53f8\u4e86\uff1b<\/span><\/p>\n<p><span style=\"font-size: 16px;\">6.&nbsp;\u6682\u65f6\u6027\u6279\u51c6\uff08Tentative Approval\uff09\u7684\u4f01\u4e1a\u54c1\u79cd\u670912\u4e2a\uff1b<\/span><\/p>\n<p><span style=\"font-size: 16px;\">7.&nbsp;2018\u5e749\u670812\u65e5\uff0c\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\u516c\u544a\uff0c\u5176\u5236\u5242\u4ea7\u54c1\u76d0\u9178\u4e8c\u7532\u53cc\u80cd\u7f13\u91ca\u7247\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\u6587\u53f7\u3002<\/span><\/p>\n<p><br  \/><\/p>\n<p><span style=\"font-size: 16px;\">\u76d0\u9178\u4e8c\u7532\u53cc\u80cd\u7f13\u91ca\u7247\u7531\u767e\u65f6\u7f8e\u65bd\u8d35\u5b9d\u516c\u53f8\uff08Bristol Myers Squibb\uff09\u7814\u53d1\uff0c\u4e8e2000\u5e74\u5728\u7f8e\u56fd\u4e0a\u5e02\u3002\u76ee\u524d\u5728\u4e2d\u56fd\u5e02\u573a\uff0c\u4e5f\u6709\u591a\u5bb6\u836f\u4f01\u751f\u4ea7\u8be5\u4ea7\u54c1\u3002\u534e\u6d77\u836f\u4e1a\u76ee\u524d\u5728\u76d0\u9178\u4e8c\u7532\u53cc\u80cd\u7f13\u91ca\u7247\u9879\u76ee\u4e0a\u5df2\u6295\u5165\u7814\u53d1\u8d39\u7528\u7ea6600\u4e07\u5143\u4eba\u6c11\u5e01;<\/span><\/p>\n<p><br  \/><\/p>\n<p><span style=\"font-size: 16px;\">8.&nbsp;https:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ApprovedDrugs\/ApprovedDrugProductswithTherapeuticEquivalenceEvaluationsOrangeBook\/default.htm\uff1bhttps:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm?event=reportsSearch.process\uff1b<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"color: rgb(217, 33, 66);\"><strong><font size=\"4\">\u5ef6\u4f38\u9605\u8bfb\uff1a<\/font><\/strong><\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;color: rgb(0, 82, 255);\">1\u3001ANDA\u7533\u8bf7<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">Abbrevitive New Drug Application(\u7b80\u7565\u65b0\u836f\u7533\u8bf7)\uff0c\u7b80\u79f0ANDA\u3002\u6839\u636e\u7f8e\u56fd\u300a\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u300b\uff08FDCA\uff09\u53ca\u7f8e\u56fd\u8054\u90a6\u7ba1\u7406\u6cd521 CFR Part 21\uff0c\u4e13\u5229\u671f\u8fc7\u540e\u7684\u901a\u7528\u540d\u836f\u5747\u6309\u6b64\u7a0b\u5e8f\u7533\u8bf7\u4e0a\u5e02\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u4f46\u662f\uff0c\u300a\u836f\u54c1\u4ef7\u683c\u7ade\u4e89\u548c\u4e13\u5229\u671f\u6062\u590d\u6cd5\uff08Waxman-Hatch Act\uff09\u300b\u5e76\u4e0d\u9002\u7528\u4e8e\u751f\u7269\u5236\u54c1\uff0c\u5373\u751f\u7269\u5236\u54c1\u4e0d\u80fd\u6309ANDA\u6279\u51c6\u4e0a\u5e02\u3002\u8fc4\u4eca\u5df2\u6709\u4e0d\u5c11\u8bd5\u56fe\u4e89\u53d6\u751f\u7269\u5236\u54c1\u4eff\u5236\u7684\u6e38\u8bf4\uff0c\u4f46\u5c1a\u65e0\u76f8\u5173\u6cd5\u5f8b\u51fa\u53f0\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u7f8e\u56fd\u7684ANDA\u6ce8\u518c\u76f8\u5f53\u4e8e\u4e2d\u56fd\u7684\u4eff\u5236\u836f\u6ce8\u518c\uff0c\u76f8\u5bf9\u65b0\u836f\u6ce8\u518c\u8981\u7b80\u5355\u3002\u6839\u636e\u4e2d\u56fd\u5b9e\u9645\u60c5\u51b5\uff0c\u5728\u7f8e\u56fd\u8fdb\u884c\u4eff\u5236\u836f\u6ce8\u518c\uff0c\u5373ANDA \u7533\u8bf7\uff0c\u9002\u5408\u4e2d\u56fd\u7684\u5927\u4e2d\u578b\u836f\u5382\u3002\u5370\u5ea6\u5728\u8fd9\u65b9\u9762\u8fdc\u9886\u5148\u4e8e\u4e2d\u56fd\uff0c\u76ee\u524d\u7ea630%\u7684ANDA\u662f\u7531\u5370\u5ea6\u5382\u5bb6\u7533\u8bf7\u7684\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;color: rgb(0, 82, 255);\">2\u3001ANDA\u7533\u8bf7\u4eba\u8d44\u683c<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">ANDA\u7684\u7533\u8bf7\u4eba\u53ef\u4ee5\u662f\u201c\u4efb\u4f55\u4eba\u201d\uff08any person\uff09\uff0c\u5373\u539f\u5219\u4e0a\u4e0d\u5fc5\u662f\u516c\u53f8\uff08\u6cd5\u4eba\uff09\uff0c\u4e5f\u4e0d\u533a\u5206\u56fd\u522b\uff0c\u800c\u4e14\uff0cANDA\u7684\u7533\u8bf7\u4eba\u548c\u6709\u5173\u7684\u300a\u516c\u6c11\u8bf7\u613f\u4e66\u300b\u8bf7\u613f\u4eba\u5747\u53ef\u662f\u975e\u7f8e\u56fd\u516c\u6c11\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u4f46\u5728\u5b9e\u9645\u64cd\u4f5c\u4e0a\uff0cANDA\u5e94\u8be5\u6709\u8db3\u4ee5\u5904\u7406\u95ee\u9898\u7684\u7f8e\u56fd\u4ee3\u7406\u4eba\uff0c\u4e0eFDA\u4fdd\u6301\u8054\u7edc\uff0c\u5904\u7406\u6ce8\u518c\u4e8b\u5b9c\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;color: rgb(0, 82, 255);\">3\u3001\u62df\u6ce8\u518c\u836f\u54c1\u7684\u8d44\u683c<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u62df\u5411FDA\u7533\u8bf7ANDA\u7684\u836f\u54c1\uff0c\u5e94\u4e3a\u5df2\u88abFDA\u6279\u51c6\u4e0a\u5e02\u7684\uff0c\u5728\u300a\u7ecf\u6cbb\u7597\u7b49\u540c\u6027\u8bc4\u4ef7\u6279\u51c6\u7684\u836f\u54c1\uff08\u6a59\u76ae\u4e66\uff09\u300b\u4e2d\u6536\u8f7d\u5e76\u6307\u5b9a\u53c2\u6bd4\u5236\u5242\uff08Reference Listed Drug\uff09\u7684\u836f\u54c1\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u5982\u7533\u8bf7\u4eba\u62df\u4eff\u5236\u5728\u300a\u6a59\u76ae\u4e66\u300b\u4e2d\u6536\u8f7d\u4f46\u5e76\u672a\u5236\u5b9a\u53c2\u6bd4\u5236\u5242\u7684\u836f\u54c1\uff0c\u987b\u5148\u63d0\u4ea4\u300a\u516c\u6c11\u8bf7\u613f\u4e66\u300b\u8bf7\u6c42FDA\u5c06\u8be5\u836f\u54c1\u6307\u5b9a\u4e3a\u53c2\u6bd4\u5236\u5242\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u62df\u7533\u8bf7ANDA\u7684\u836f\u54c1\uff0c\u5176\u6d3b\u6027\u6210\u5206\u3001\u5242\u578b\u3001\u89c4\u683c\u3001\u7ed9\u836f\u9014\u5f84\u3001\u9002\u5e94\u75c7\u5fc5\u987b\u4e0e\u53c2\u6bd4\u5236\u5242\u76f8\u540c\uff0c\u82e5\u62df\u7533\u8bf7ANDA\u7684\u836f\u54c1\u7684\u4e0a\u8ff0\u6761\u4ef6\u4e0e\u53c2\u6bd4\u5236\u5242\u4e0d\u540c\uff0c\u5219\u9700\u5148\u9012\u4ea4\u6709\u5173\u300a\u516c\u6c11\u8bf7\u613f\u4e66\u300b\uff0c\u83b7\u5f97FDA\u6279\u51c6\u4e4b\u540e\uff0c\u65b9\u80fd\u63d0\u51faANDA\u7533\u8bf7\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u62df\u7533\u8bf7ANDA\u7684\u836f\u54c1\uff0c\u5fc5\u987b\u4e0e\u53c2\u6bd4\u5236\u5242\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<p><span style=\"font-size: 18px;\">\u62df\u7533\u8bf7ANDA\u7684\u836f\u54c1\uff0c\u5fc5\u987b\u6309\u7167\u7f8e\u56fd\u8054\u90a6\u7ba1\u7406\u6cd521 CFR\u9075\u884c\u836f\u54c1\u751f\u4ea7\u7ba1\u7406\u89c4\u8303\u63a7\u5236\u751f\u4ea7\u8fc7\u7a0b\u3002<\/span><\/p>\n<p><span style=\"font-size: 18px;\"><br  \/><\/span><\/p>\n<\/p>\n<p style=\"white-space: normal;\"><span style=\"font-size: 18px;\"><\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"list-style-type: square;\">\n<li>\n<p><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MjM5OTYyODk5Mg==&amp;mid=2651034239&amp;idx=2&amp;sn=a37628bde0725850a5dbdf984de6eca7&amp;chksm=bccfabd08bb822c6813b4e36d795968e9299cabb3f827b20d56703b3b5188f719c91aa206c61&amp;scene=21#wechat_redirect\" target=\"_blank\" style=\"text-decoration: underline;\"><span style=\"color: rgb(0, 82, 255);\">\u9080\u60a8\u52a0\u5165\u5168\u56fd1000\u4e2a\u533b\u836f\u7fa4<\/span><\/a><\/p>\n<\/li>\n<\/ul>\n<p style=\"white-space: normal;\"><br  \/><\/p>\n<p style=\"white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box;color: rgb(62, 62, 62);\"><span style=\"color: rgb(136, 136, 136);font-size: 14px;\">\u672c\u5e73\u53f0\u4e0d\u5bf9\u8f6c\u8f7d\u4e4b\u6587\u7ae0\u6240\u5305\u542b\u5185\u5bb9\u7684\u51c6\u786e\u6027\u3001\u53ef\u9760\u6027\u6216\u8005\u5b8c\u6574\u6027\u63d0\u4f9b\u4efb\u4f55\u660e\u793a\u6216\u6697\u793a\u7684\u4fdd\u8bc1\uff0c\u4e0d\u5bf9\u6587\u7ae0\u89c2\u70b9\u8d1f\u8d23\u3002<\/span><\/p>\n<p style=\"white-space: normal;background-color: rgb(255, 255, 255);box-sizing: border-box;color: rgb(62, 62, 62);\"><span style=\"color: rgb(136, 136, 136);font-size: 14px;\"><br  \/><\/span><\/p>\n<p style=\"font-size: 16px;white-space: normal;color: rgb(62, 62, 62);line-height: 25.6px;font-variant-ligatures: normal;font-variant-east-asian: normal;font-variant-position: normal;word-wrap: break-word;min-height: 16px;max-width: 769px;box-sizing: border-box;orphans: 2;background-color: rgb(255, 255, 255);\"><span style=\"color: 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