UPDATE 1-FDA rejects Merck's application to add heart data on diabetes drug labels

UPDATE 1-FDA rejects Merck's application to add heart data on diabetes drug labels


Merck & Co said the U.S. Food and Drug Administration declined an application to include information on the labels of its diabetes drugs - Januvia and Janumet - that the treatments do not raise the risk of major heart problems. The application was submitted on the basis of a keenly watched study in 14,724 patients with type 2 diabetes and a history of heart disease.



from Biotech News