Merck receives FDA approval for expanded labeling of Januvia

-Trading Markets

10/19/2007 - Merck & Co. has received FDA approval for expanded labeling of Januvia (sitagliptin), the only DPP-4 inhibitor available in the US for the treatment of type 2 diabetes. Januvia is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes.

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.

Ennis & Ennis, P.A. is representing individuals that have Stevens Johnson Syndrome due to side effects of prescription drugs. For more information about a Steven's Johnson Syndrome related lawsuit click here to contact our lawyers for a free, confidential case evaluation.