Merck receives FDA approval for expanded labeling of Januvia

The new regimens with Januvia described in the updated labeling include, as an adjunct to diet and exercise, initial therapy in combination with metformin; add-on therapy to a sulfonylurea (glimepiride) when the single agent alone does not provide adequate glycemic control; and, add-on therapy to the combination of a sulfonylurea (glimepiride) and metformin when dual therapy does not provide adequate glycemic control.

The expanded labeling for Januvia was also updated to include post-marketing reports of hypersensitivity reactions in patients treated with Januvia. These reactions include anaphylaxis, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome. The expanded labeling includes a contraindication for patients with history of a serious hypersensitivity reaction to sitagliptin, including anaphylaxis and angioedema.