- a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease;
- a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
- an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents;
- two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
- an enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.
 FDA News Release, "FDA approves Farxiga to treat type 2 diabetes" (Jan. 8, 2014).