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FDA approves three Takeda diabetes products

January 26, 2013 2:37 AM UTC

FDA approved three products on Friday from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) as an adjunct to diet and exercise to improve blood sugar control in adult Type II diabetics. The agency approved Nesina alogliptin, for which Takeda is required to conduct five postmarketing studies, including a cardiovascular outcomes trial. FDA also approved Kazano alogliptin/metformin and Oseni alogliptin/pioglitazone. Kazano's label includes a boxed warning for lactic acidosis associated with metformin use, and Oseni's label includes a boxed warning for heart failure associated with pioglitazone use. Kazano is a fixed-dose combination of alogliptin and metformin, and Oseni is a fixed-dose combination of alogliptin and Takeda's Actos pioglitazone. Alogliptin is a dipeptidyl peptidase-4 (DDP-4) inhibitor. ...