FDA accepts NDA for combination of empagliflozin, linagliptin and metformin extended release for the treatment of adults with type 2 diabetes
The FDA has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly announced.
The NDA is based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin and metformin XR investigational fixed-dose combination tablets and their individual components in healthy adults. Boehringer Ingelheim and Lilly plan to present results from the trials at a medical congress later this year.
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