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FDA Panel Rejects AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Diabetes Pill


7/19/2011 2:58:52 PM

U.S. advisers rejected a new type of diabetes pill from AstraZeneca (AZN.L) and Bristol-Myers Squibb (BMY.N) over concerns about liver and cancer risks. A Food and Drug Administration advisory panel voted 9-6 on Tuesday against recommending approval of the drug, called dapagliflozin, for adults with Type 2 diabetes. Panel members said the clinical data did not provide enough certainty about the drug's cancer, liver and kidney risks, as well as its efficacy -- especially for the elderly. The FDA usually follows the recommendations of its advisory panels and is due to make a final decision on the drug by Oct. 28.

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