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Januvia Clears FDA; Sitagliptin Has “Neutral Effects” On Weight, Agency Says

Executive Summary

Merck's dipeptidyl peptidase IV inhibitor Januvia has no significant effect on weight, FDA said after approving sitagliptin for type 2 diabetes Oct. 16

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Expanded indications for Januvia

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...

Expanded indications for Januvia

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...

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