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FDA issues "not approvable" letter for bromocriptine for type 2 diabetes Nov. 20, citing the "overall benefit to risk ratio" of the product. In June, the agency requested that Ergo Science propose a clinical plan to address durability of bromocriptine's effect on glycosolated hemoglobin and ancillary safety effects due to the neuroendocrine mechanism of action. The company said it is considering its options, including an appeal of the letter
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