Merck’s Combination Of Ezetimibe And Atorvastatin Combo Back On NDA Path

A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son of Vytorin.” The new drug application (NDA) submission was first rejected by the FDA in 2009 and, again, last year. Merck said yesterday that the FDA had accepted Merck’s resubmission of its NDA, which included additional data provided by Merck in More…
Source: CardioBrief - Category: Cardiology Authors: Tags: Prevention, Epidemiology & Outcomes cholesterol ezetimibe FDA food and drug administration LDL cholesterol lovastatin Merck New Drug Application vytorin Source Type: blogs