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. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 3, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 2, 2013 - Merck
(NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA)
has acknowledged the resubmission of a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 3, 2013 Category: Drugs & Pharmacology Source Type: news
Lipid lowering efficacy of atorvastatin
Source: Cochrane
Area: Evidence > Drug Specific Reviews
Background
Atorvastatin is one of the most widely prescribed drugs and the most widely prescribed statin in the world. It is therefore important to know the dose-related magnitude of effect of atorvastatin on blood lipids.
Objectives
To quantify the dose-related effects of atorvastatin on blood lipids and withdrawals due to adverse effects (WDAE).
Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library Issue 4, 2011, MEDLINE (1966 t...
Source: NeLM - Cardiovascular Medicine - January 3, 2013 Category: Cardiology Source Type: news
Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets
Dateline City:
WHITEHOUSE STATION, N.J.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Food and Drug Administration (FDA) has
acknowledged the resubmission of a New Drug Application (NDA) for
ezetimibe and atorvastatin tablets, an investigational combination
medicine. The updated NDA was deemed complete for review after Merck
submitted additional data in response to the FDA’s Complete Response
Letter issued last year.
...
Source: Merck.com - Research and Development News - January 2, 2013 Category: Pharmaceuticals Authors: hq_site_admin Tags: Research and Development News Source Type: news
Merck Announces FDA Acknowledgement Of Resubmission Of New Drug Application For Ezetimibe/Atorvastatin Tablets
Merck, known as MSD outside the United States and Canada, announced recently that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - January 2, 2013 Category: Pharmaceuticals Source Type: news
Injunction against the supply of generic atorvastatin - advice for pharmacists
The Royal Pharmaceutical Society has received enquiries from members about the distribution and sale of generic atorvastatin. Due to this, we have produced the following advice for our members.
&nbs (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - June 28, 2011 Category: Drugs & Pharmacology Source Type: news
Nova Scotians to Pay Less for Drugs
Nova Scotians covered by the Pharmacare programs and taxpayers will pay less for the generic form of Lipitor as a result of government's plan to get fair drug prices. (Source: Government of Nova Scotia News Releases - Health)
Source: Government of Nova Scotia News Releases - Health - November 10, 2010 Category: American Health Authors: Health (To Jan. 11) Source Type: news
Counterfeit Drug Information for Kidney Cancer Patients
In today's global environment, it doesn't matter if you live in United States, Europe, Asia, or Africa—everyone is at risk from unsafe drugs. Counterfeit drugs defraud consumers and deny patients therapies that can alleviate suffering and save lives. Unfortunately, in some cases, these drugs have caused great harm and fatalities.
But there are ways to minimize your risk of getting a counterfeit medicine while still saving money on your treatment. The Kidney Cancer Association has partnered with the Partnership for Safe Medicines to collect important information about counterfeit drugs. Take a moment to learn more ab...
Source: Kidney Cancer Association - June 14, 2009 Category: Urology & Nephrology Source Type: news
Counterfeit Drug Information for Kidney Cancer Patients
In today's global environment, it doesn't matter if you live in United States, Europe, Asia, or Africa—everyone is at risk from unsafe drugs. Counterfeit drugs defraud consumers and deny patients therapies that can alleviate suffering and save lives. Unfortunately, in some cases, these drugs have caused great harm and fatalities.But there are ways to minimize your risk of getting a counterfeit medicine while still saving money on your treatment. The Kidney Cancer Association has partnered with the Partnership for Safe Medicines to collect important information about counterfeit drugs. Take a moment to learn more abou...
Source: Kidney Cancer Association - June 14, 2009 Category: Urology & Nephrology Source Type: news
