Merck’s Combination Of Ezetimibe And Atorvastatin 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 ...
Source: CardioBrief - January 3, 2013 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes cholesterol ezetimibe FDA food and drug administration LDL cholesterol lovastatin Merck New Drug Application vytorin Source Type: blogs
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 ...
Source: CardioBrief - January 3, 2013 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes cholesterol ezetimibe FDA food and drug administration LDL cholesterol lovastatin Merck New Drug Application vytorin Source Type: blogs
Yes, Statins do everything – even lower BP
What could be crazy enough to end a 4 month hibernation of CTE?
Archives Int Med 4/08 – The UCSD Statin study yielded further evidence that statin treatment reduces blood pressure (although not by much) The RCT enrolled over 900 subjects without known CVD or diabetes. The idea was to independently assess the effect on BP. There was no inclusion / exclusion criteria regarding baseline BP. Subjects were randomized to pravastatin, simvastatin, or placebo.
Treatment with a statin resulted in about a 2-2.5 point drop in SBP and DBP. The treatment was stopped at 6 months, and the blood pressures returned to baseline by mo...
Source: Consider The Evidence: Med/Peds Journal Roundup - April 17, 2008 Category: Internists and Doctors of Medicine Authors: medblog Tags: archives of internal medicine hypertension Source Type: blogs
