Expanded indications for Januvia
Executive Summary
Merck's type 2 diabetes agent is approved as first-line therapy in combination with metformin and as an add-on to a sulfonylurea or sulfonylurea and metformin combination regimen, Merck says Oct. 17. Januvia (sitagliptin), the only marketed DPP-4 inhibitor, is indicated for improvement of glycemic control in adults with type 2 diabetes (1"The Pink Sheet" Oct. 23, 2006, p. 6). Labeling is also updated to include hypersensitivity reactions - including anaphylaxis, angioedema and exfoliative skin conditions - in the Warnings and Precautions sections...
Merck's type 2 diabetes agent is approved as first-line therapy in combination with metformin and as an add-on to a sulfonylurea or sulfonylurea and metformin combination regimen, Merck says Oct. 17. Januvia (sitagliptin), the only marketed DPP-4 inhibitor, is indicated for improvement of glycemic control in adults with type 2 diabetes (1 (Also see "Januvia Clears FDA; Sitagliptin Has “Neutral Effects” On Weight, Agency Says" - Pink Sheet, 23 Oct, 2006.), p. 6). Labeling is also updated to include hypersensitivity reactions - including anaphylaxis, angioedema and exfoliative skin conditions - in the Warnings and Precautions sections.... |