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PD-0332991, a potent and selective inhibitor of cyclin-dependent kinase 4/6, demonstrates inhibition of proliferation in renal cell carcinoma at nanomolar concentrations and molecular markers predict for sensitivity

321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in the labeling," said FDA in their letter to Guangzhou Huli based in Chicago