The US Food and Drug Administration (FDA) has approved an expanded indication for insulin Tresiba (insulin degludec). Tresiba has been approved for use in children and adolescents with type 1 and type 2 diabetes. Tresiba was shown to effectively improve blood sugar levels in combination with insulin NovoRapid. Tresiba is the only basal insulin to be approved for both type 1 diabetes and type 2 diabetes in patients as young as one.

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Synjardy wins FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Synjardy® XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. Synjardy XR combines empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Synjardy XR will be available as 5 mg/1000 mg and 12.5 mg/1000 mg strength tablets and as 10 mg/1000 mg and 25 mg/1000 mg strength tablets.

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Cancer, weight gain, edema and bone fractures still a concern with long term use of Pioglitazone

The US Food and Drug Administration (FDA) says that it still believes the type 2 diabetes drug pioglitazone (Actos) may pose an increased risk for bladder cancer after updating its review of published research. A retrospective cohort study published in the BMJ earlier this year reported a 63% higher risk for bladder cancer for pioglitazone, with longer duration and larger doses increasing the risk.
The FDA said in a news release that after analyzing the new data since 2011, it has concluded — again — that pioglitazone may be linked to an increased risk for bladder cancer. The agency will update the drug's label to describe the additional studies it reviewed.

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