Two-year carcinogenicity studies in rats and mice have also been completed.

使用大小鼠进行的两年致癌性研究也已经完成。

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However, a team of FDA toxicology experts reviewed the lorcaserin NDA and interpreted the data related to the lorcaserin carcinogenicity studies.

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Arena is going to need to agree with the FDA on an independent pathologist to figure out a path forward on the rat carcinogenicity studies it has already done and possibly do more animal experiments.

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Moreover, the lorcaserin carcinogenicity studies were also thoroughly reviewed and discussed by the Center for Drug Evaluation and Research (CDER) Executive Carcinogenicity Assessment Committee, and the results of this scientific assessment were included in the background documents provided to the committee and discussed in Agency presentations at the Advisory Committee meeting.

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