FDA rejects Merck’s application to add heart data to labelling for diabetes drugs

This article was originally published here

Merck has received a complete response letter from the US Food and Drug Administration (FDA) seeking to add cardiovascular outcomes data from the TECOS study to the labels of J Januvia (sitagliptin), Janumet (sitagliptin and metformin), and Janumet XR (sitagliptin and metformin extended-release).

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