FDA's decision not to approve AstraZeneca PLC's fixed-dose product combining two oral antidiabetic agents comes with a somewhat surprising request – more clinical data.
AstraZeneca Diabetes Combo Needs More Clinical Data, FDA Says
Even though both components are already marketed, firm might have to do another study for fixed-dose combination of DPP-4 inhibitor saxagliptin and SGLT2 inhibitor dapagliflozin.