在此次撤市之后，麦罗塔将来在美国的任何一种使用都将需要向FDA提交一项研究性新药申请。

Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.

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如适用，在新药申请中，交叉验证研究数据的信息。

In NDA submissions, information about cross-validation study data, if applicable.

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本研究基本完成了国家一类新药制剂学部分的临床前资料，处方已申请专利。

The preclinical study of it as lnd category new drug of China have been finished basically and the formulation has been patented.

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