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FDA批准酶替代药品Ultresa和Viokace

2012-03-04 MedSci MedSci原创

FDA胰酶UltresaViokace胰腺
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    2012年3月2日FDA批准了两种用于治疗胰腺功能缺陷的酶替代新药品。         两种新药品(Ultresa和Viokace)均属于胰酶脂肪酶类别，旨在帮助患者（导致胰功能不全的疾病）消化食物。         两种药品具体适应症有所不同。    

    2012年3月2日FDA批准了两种用于治疗胰腺功能缺陷的酶替代新药品。

        两种新药品(Ultresa和Viokace)均属于胰酶脂肪酶类别，旨在帮助患者（导致胰功能不全的疾病）消化食物。

        两种药品具体适应症有所不同。

        FDA表示，Ultresa是缓释胶囊，被批准用于治疗儿童和成人囊肿性纤维化，或者其他导致胰酶释放明显不足的疾病。

        Viokace用于治疗成人慢性胰腺炎、部分或全部胰腺切除的患者，需要与质子泵抑制剂同服。

        该机构说，Viokace用于儿童的安全性和有效性尚未被证实。

        FDA强调说，胰酶替代品在没有批准的情况下已经销售多年。截至2010年四月，经销商必须有正式的批准才能销售。

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    2012-11-20 shanyongle

    #ACE#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1655644, encodeId=bbc21655644d4, content=<a href='/topic/show?id=2a011829d7' target=_blank style='color:#2F92EE;'>#ACE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1829, encryptionId=2a011829d7, topicName=ACE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=635024767990, createdName=shanyongle, createdTime=Tue Nov 20 21:05:00 CST 2012, time=2012-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796586, encodeId=f99b1e9658616, content=<a href='/topic/show?id=31331812684' target=_blank style='color:#2F92EE;'>#Ultresa#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18126, encryptionId=31331812684, topicName=Ultresa)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca772500164, createdName=ms1490123962508630, createdTime=Mon Jan 21 15:05:00 CST 2013, time=2013-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839140, encodeId=752a1839140dc, 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=38, 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=Tue Jun 12 03:05:00 CST 2012, time=2012-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796427, encodeId=eb111e96427b7, content=<a href='/topic/show?id=54ca1e800f6' target=_blank style='color:#2F92EE;'>#tRES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17800, encryptionId=54ca1e800f6, topicName=tRES)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Wed May 09 16:05:00 CST 2012, time=2012-05-09, status=1, ipAttribution=)]
    2013-01-21 ms1490123962508630

    #Ultresa#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1655644, encodeId=bbc21655644d4, content=<a href='/topic/show?id=2a011829d7' target=_blank style='color:#2F92EE;'>#ACE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1829, encryptionId=2a011829d7, topicName=ACE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=635024767990, createdName=shanyongle, createdTime=Tue Nov 20 21:05:00 CST 2012, time=2012-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796586, encodeId=f99b1e9658616, content=<a href='/topic/show?id=31331812684' target=_blank style='color:#2F92EE;'>#Ultresa#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18126, encryptionId=31331812684, topicName=Ultresa)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca772500164, createdName=ms1490123962508630, createdTime=Mon Jan 21 15:05:00 CST 2013, time=2013-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839140, encodeId=752a1839140dc, 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=38, 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=Tue Jun 12 03:05:00 CST 2012, time=2012-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796427, encodeId=eb111e96427b7, content=<a href='/topic/show?id=54ca1e800f6' target=_blank style='color:#2F92EE;'>#tRES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17800, encryptionId=54ca1e800f6, topicName=tRES)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Wed May 09 16:05:00 CST 2012, time=2012-05-09, status=1, ipAttribution=)]
    2012-06-12 bugit

    #FDA批准#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1655644, encodeId=bbc21655644d4, content=<a href='/topic/show?id=2a011829d7' target=_blank style='color:#2F92EE;'>#ACE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1829, encryptionId=2a011829d7, topicName=ACE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=635024767990, createdName=shanyongle, createdTime=Tue Nov 20 21:05:00 CST 2012, time=2012-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796586, encodeId=f99b1e9658616, content=<a href='/topic/show?id=31331812684' target=_blank style='color:#2F92EE;'>#Ultresa#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18126, encryptionId=31331812684, topicName=Ultresa)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ca772500164, createdName=ms1490123962508630, createdTime=Mon Jan 21 15:05:00 CST 2013, time=2013-01-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839140, encodeId=752a1839140dc, 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=38, 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=Tue Jun 12 03:05:00 CST 2012, time=2012-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1796427, encodeId=eb111e96427b7, content=<a href='/topic/show?id=54ca1e800f6' target=_blank style='color:#2F92EE;'>#tRES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17800, encryptionId=54ca1e800f6, topicName=tRES)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/2898B09F0DA89357D0D54A725E611AC7/100, createdBy=fdd32500040, createdName=ms7899726347904398, createdTime=Wed May 09 16:05:00 CST 2012, time=2012-05-09, status=1, ipAttribution=)]
    2012-05-09 ms7899726347904398

    #tRES#

    0

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