The FDA announced the approval of Jardiance (empagliflozin; Boehringer Ingelheim and Eli Lilly) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor that works by blocking the reabsorption of glucose by the kidney. This increases glucose excretion and lowers blood glucose levels.

The safety and efficacy of Jardiance were studied in seven clinical trials with 4,480 patients with type 2 diabetes. The study results showed that Jardiance improved hemoglobin A1c levels compared to placebo. In addition, Jardiance has been studied as monotherapy and combination therapy with other antidiabetic therapies, including metformin, sulfonylureas, pioglitazone, and insulin.

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The FDA is requiring the following four postmarketing studies for Jardiance: completion of an ongoing cardiovascular outcomes trial, a pediatric pharmacokinetic/pharmacodynamic study, a pediatric safety and efficacy study, and a nonclinical juvenile toxicity study with a focus on renal development, bone development, and growth.

Jardiance will be available in 10mg and 25mg tablets in 30- and 90-count bottles. 

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