Merck Januvia Becomes First DPP IV Inhibitor NDA; Novartis Galvus Is Close Behind
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
After a busy 2005 that included clearing two first-in-class diabetes agents, FDA’s Endocrine & Metabolic Drugs Division is starting to review the first wave of NDAs for another new class of anti-diabetic, the dipeptidyl peptidase IV inhibitors.