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惠氏(Wyeth)公司的抗生素产品tigecycline(商品名为Tygacil)用于治疗社区获得性肺炎(CAP)的补充新药申请(sNDA)已收到美国FDA的“可获准”批件,但FDA在批件中要求公司另外提供有关本品肝毒性的风险-疗效比数据。该公司最近称,它已向FDA提交了相关资料,并相信这些信息资料足以解
Wyeth’s antibiotic product tigecycline (Tygacil) has been approved by the FDA for approval of the New Drug Application (sNDA) for use in community-acquired pneumonia (CAP), but the FDA has requested in the document The company additionally provides information about the risk-benefit ratio of this product for hepatotoxicity. The company recently said it has submitted the relevant information to the FDA and believes the information is sufficient