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华生布地奈德雾化吸入混悬液ANDA获FDA批准

2012-08-02 potato 生物谷

华生布地奈德雾化吸入混悬液FDA
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华生（Waston）今天宣布，旗下子公司华生实验室（Watson Laboratories）布地奈德雾化吸入混悬液（Budesonide Inhalation Suspension，0.25mg/2mL,0.5mg/2mL Unit-dose ampules）简化新药申请（ANDA）已获FDA批准。该药是阿斯利康（AstraZeneca）普米克令舒（Pulmicort RESPULES）的等效仿制

华生（Waston）今天宣布，旗下子公司华生实验室（Watson Laboratories）布地奈德雾化吸入混悬液（Budesonide Inhalation Suspension，0.25mg/2mL,0.5mg/2mL Unit-dose ampules）简化新药申请（ANDA）已获FDA批准。该药是阿斯利康（AstraZeneca）普米克令舒（Pulmicort RESPULES）的等效仿制药。

华生目前正卷入与阿斯利康该产品的专利诉讼。如果该诉讼的初步禁止令议案能获得预期的有利结果，华生计划在今年就推出该产品。

根据IMS数据，截止2012年5月31日，Pulmicort RESPULES在美国的年销售额为11亿美元。Pulmicort RESPULES是一种维持性药物，用于控制和预防12个月~8岁儿童的哮喘症状。

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#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1839172, encodeId=afd118391e244, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Sat Apr 13 06:47:00 CST 2013, time=2013-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1457710, encodeId=ae20145e71023, content=<a href='/topic/show?id=e2d1988611e' target=_blank style='color:#2F92EE;'>#雾化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98861, encryptionId=e2d1988611e, topicName=雾化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b79433, createdName=jiangjun073, createdTime=Sat Aug 04 01:47:00 CST 2012, time=2012-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581034, encodeId=46f21581034c5, content=<a href='/topic/show?id=3beb12600e5' target=_blank style='color:#2F92EE;'>#NDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12600, encryptionId=3beb12600e5, topicName=NDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a9e16702381, createdName=12498a49m65暂无昵称, createdTime=Sat Aug 04 01:47:00 CST 2012, time=2012-08-04, status=1, ipAttribution=)]
    2013-04-13 bugit

    #FDA批准#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1839172, encodeId=afd118391e244, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Sat Apr 13 06:47:00 CST 2013, time=2013-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1457710, encodeId=ae20145e71023, content=<a href='/topic/show?id=e2d1988611e' target=_blank style='color:#2F92EE;'>#雾化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98861, encryptionId=e2d1988611e, topicName=雾化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b79433, createdName=jiangjun073, createdTime=Sat Aug 04 01:47:00 CST 2012, time=2012-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581034, encodeId=46f21581034c5, content=<a href='/topic/show?id=3beb12600e5' target=_blank style='color:#2F92EE;'>#NDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12600, encryptionId=3beb12600e5, topicName=NDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a9e16702381, createdName=12498a49m65暂无昵称, createdTime=Sat Aug 04 01:47:00 CST 2012, time=2012-08-04, status=1, ipAttribution=)]
    2012-08-04 jiangjun073

    #雾化#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1839172, encodeId=afd118391e244, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Sat Apr 13 06:47:00 CST 2013, time=2013-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1457710, encodeId=ae20145e71023, content=<a href='/topic/show?id=e2d1988611e' target=_blank style='color:#2F92EE;'>#雾化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98861, encryptionId=e2d1988611e, topicName=雾化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b79433, createdName=jiangjun073, createdTime=Sat Aug 04 01:47:00 CST 2012, time=2012-08-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581034, encodeId=46f21581034c5, content=<a href='/topic/show?id=3beb12600e5' target=_blank style='color:#2F92EE;'>#NDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12600, encryptionId=3beb12600e5, topicName=NDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9a9e16702381, createdName=12498a49m65暂无昵称, createdTime=Sat Aug 04 01:47:00 CST 2012, time=2012-08-04, status=1, ipAttribution=)]
    2012-08-04 12498a49m65暂无昵称

    #NDA#

    0