FDA APPROVAL FOR HPBCD AS ORPHAN DRUG

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FDA APPROVAL FOR HPBCD AS ORPHAN DRUG

机译：FDA批准HPBCD为孤儿药

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CD NEWS reported 2 months ago that the mother of tween daughters suffering from a fatal cholesterol metabolism deficiency (Niemann-Pick Type C disease) applied for orphan drug status of hydroxypropyl-beta-cyclodextrin (HPΒCD). Now we are pleased to inform the readers of CD NEWS that she just received a positive message from FDA and the approval was granted1. This is the second time (the first one was Sugammadex or Bridion~R) that a cyclodextrin itself has been designated as a drug. This designation is an important milestone in the history of pharmaceutical use of cyclodextrins. Cyclodextrin, at least HPBCD, when administered at really high doses and as a chronic treatment, intravenously, cannot be considered any more as an inert excipient.

机译：CD News 2个月前报道说，患有致命胆固醇代谢缺乏症（Niemann-Pick型C疾病）的育成女儿的母亲适用于羟基丙烷-beta-cyclodextrin（HPβCD）的孤儿药物状况。现在，我们很高兴将CD News告知读者，她刚刚收到了FDA的积极信息，并获得了批准1。这是第二次（第一次是sugammadex或bridion〜r），循环克服蛋白本身已被指定为药物。该名称是循环使用循环使用史的重要里程碑。至少以高剂量给药时，环糊精至少HPBCD，并且作为一种慢性治疗，静脉注射，不能再被视为惰性赋形剂。

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《Cyclodextrin news》 |2010年第5期|3-3|共1页
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Cyclodextrin news Group;
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中图分类世界政治概况;
关键词
Orphan Drug; Mother; CyclodextrinsReader Device ComponentapprovalNiemann-Pick's Disease Type CSugammadexbeta-hydroxypropylcyclodextrinPharmaceutical Preparations;

机译：孤儿药;母亲;环糊精读取器设备componentApproval niemann-pick的疾病型csugammadexbeta-hydroxypropylopylopylopylopylopyclodextri药物制剂;

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3. SUPERGEN'S DECITABINE GRANTED"ORPHAN DRUG"STATUS IN EUROPE [J] . Worldwide Biotech Group Worldwide Biotech . 2003,第4期

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FDA APPROVAL FOR HPBCD AS ORPHAN DRUG

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