But the U.S. Food and Drug Administration's complete response letter did not request additional clinical trials for the drug, Saphris, and included proposed product labeling for the medicine.
A "black box" warning is the most serious type of warning on prescription druglabeling.
“黑匣子”警告是处方药标签上最严重的警告类型。
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As is standard procedure with all new drug approvals, the FDA worked with the drug's manufacturer to compose the instruction labeling accompanying Tykerb.