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FDA拒绝Mylan的Advair Diskus非专利药

2018-06-14 MedSci MedSci原创

MylanAdvairDiskus
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Mylan宣布，美国监管机构将拒绝其仿制的葛兰素史克(GlaxoSmithKline)的哮喘/慢性阻塞性肺病吸入剂Advair Diskus。该公司透露，它收到了美国食品和药物管理局(fda)的一份最新报告，指出申请中存在"小缺陷"，并将在本月晚些时候发出完整的回复信。有关缺陷的进一步细节没有透露。该公司表示，收到官方信函后，Mylan将决定是否会对2018年全年前景产生影响。这并不是Mylan的



Mylan宣布，美国监管机构将拒绝其仿制的葛兰素史克(GlaxoSmithKline)的哮喘/慢性阻塞性肺病吸入剂Advair Diskus。

该公司透露，它收到了美国食品和药物管理局(fda)的一份最新报告，指出申请中存在"小缺陷"，并将在本月晚些时候发出完整的回复信。
有关缺陷的进一步细节没有透露。

该公司表示，收到官方信函后，Mylan将决定是否会对2018年全年前景产生影响。

这并不是Mylan的仿制药第一次受挫，去年被FDA拒绝了，尽管当时还没有披露为什么该药物被认为是不可批准的。

去年，Advair Diskus（氟替卡松/沙美特罗）在美国的销售额达到16.1亿英镑。


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  1. [GetPortalCommentsPageByObjectIdResponse(id=2030228, encodeId=d04b2030228f3, content=<a href='/topic/show?id=7ee11242187' target=_blank style='color:#2F92EE;'>#Mylan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12421, encryptionId=7ee11242187, topicName=Mylan)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Tue Nov 27 12:10:00 CST 2018, time=2018-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2012707, encodeId=b0292012e078e, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Wed Apr 03 14:10:00 CST 2019, time=2019-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324484, encodeId=adc1324484a8, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Fri Jun 15 22:50:22 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324335, encodeId=f736324335e8, content=看看.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Jun 15 07:45:41 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324250, encodeId=e7eb324250c8, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Fri Jun 15 00:52:40 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324232, encodeId=0978324232b8, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Jun 14 23:40:44 CST 2018, time=2018-06-14, status=1, ipAttribution=)]
    2018-11-27 haouestc

    #Mylan#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2030228, encodeId=d04b2030228f3, content=<a href='/topic/show?id=7ee11242187' target=_blank style='color:#2F92EE;'>#Mylan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12421, encryptionId=7ee11242187, topicName=Mylan)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Tue Nov 27 12:10:00 CST 2018, time=2018-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2012707, encodeId=b0292012e078e, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Wed Apr 03 14:10:00 CST 2019, time=2019-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324484, encodeId=adc1324484a8, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Fri Jun 15 22:50:22 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324335, encodeId=f736324335e8, content=看看.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Jun 15 07:45:41 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324250, encodeId=e7eb324250c8, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Fri Jun 15 00:52:40 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324232, encodeId=0978324232b8, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Jun 14 23:40:44 CST 2018, time=2018-06-14, status=1, ipAttribution=)]
    2019-04-03 cmj8wellington

    #Dis#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=2030228, encodeId=d04b2030228f3, content=<a href='/topic/show?id=7ee11242187' target=_blank style='color:#2F92EE;'>#Mylan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12421, encryptionId=7ee11242187, topicName=Mylan)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Tue Nov 27 12:10:00 CST 2018, time=2018-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2012707, encodeId=b0292012e078e, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Wed Apr 03 14:10:00 CST 2019, time=2019-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324484, encodeId=adc1324484a8, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Fri Jun 15 22:50:22 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324335, encodeId=f736324335e8, content=看看.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Jun 15 07:45:41 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324250, encodeId=e7eb324250c8, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Fri Jun 15 00:52:40 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324232, encodeId=0978324232b8, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Jun 14 23:40:44 CST 2018, time=2018-06-14, status=1, ipAttribution=)]
    2018-06-15 大爰

    学习了谢谢分享!!

    0

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    2018-06-15 易水河

    看看.了解了解

    0

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    2018-06-15 医者仁心5538

    学习了

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=2030228, encodeId=d04b2030228f3, content=<a href='/topic/show?id=7ee11242187' target=_blank style='color:#2F92EE;'>#Mylan#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12421, encryptionId=7ee11242187, topicName=Mylan)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Tue Nov 27 12:10:00 CST 2018, time=2018-11-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2012707, encodeId=b0292012e078e, content=<a href='/topic/show?id=7d69598468' target=_blank style='color:#2F92EE;'>#Dis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5984, encryptionId=7d69598468, topicName=Dis)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c689267, createdName=cmj8wellington, createdTime=Wed Apr 03 14:10:00 CST 2019, time=2019-04-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324484, encodeId=adc1324484a8, content=学习了谢谢分享!!, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200816/e4675a86ea694f12b82202b320dc2654/12f6b900498349e994ce8f516a584d6a.jpg, createdBy=09431951290, createdName=大爰, createdTime=Fri Jun 15 22:50:22 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324335, encodeId=f736324335e8, content=看看.了解了解, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Fri Jun 15 07:45:41 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324250, encodeId=e7eb324250c8, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Fri Jun 15 00:52:40 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=324232, encodeId=0978324232b8, content=谢谢分享学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Jun 14 23:40:44 CST 2018, time=2018-06-14, status=1, ipAttribution=)]
    2018-06-14 清风拂面

    谢谢分享学习

    0

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