Draft Guidance for Industry; Availability (FDA, USA)
Diabetes News
Tag: FDA
FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications
New Draft Guidance Considers Broader Evaluations Beyond Cardiovascular Outcomes Trials
A comprehensive review of the FDA-approved labels of diabetes drugs: indications, safety, and emerging cardiovascular safety data
All currently available diabetes medications are approved for adults with T2DM with a remarkably limited number for adults with T1DM and children with T1DM or T2DM. The incorporation of emerging data on cardiovascular outcomes in FDA drug labels is expected to influence the way physicians treat patients with diabetes (Journal of Diabetes and Its Complications)
Saxagliptin (Onglyza)
This document provides the briefing material for the April 14, 2015, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to discuss the results of the cardiovascular outcomes trial (CVOT), Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus [SAVOR] (FDA)
Sanofi receives FDA approval of once-daily basal insulin toujeo®
The U.S. Food and Drug Administration (FDA) approved Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2 2015
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