Cardiovascular outcomes trial results for AstraZeneca PLC’s Onglyza (saxagliptin) and Takeda Pharmaceuticals USA Inc.’s Nesina (alogliptin) warrant new safety-related labeling for the diabetes drugs, but not distribution restrictions or market withdrawal, an FDA advisory committee said April 14.
In separate votes, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee overwhelmingly recommended labeling changes for saxagliptin and alogliptin to reflect new safety