FDA OKs Liptruzet for High LDL
(MedPage Today) -- The FDA approved Liptruzet, a combination of ezetimibe and atorvastatin, for the treatment of hyperlipidemia, drug maker Merck announced today. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 3, 2013 Category: Cardiology Source Type: news
FDA approves atorvastatin/ezetimibe combo tablet
The combination, known as Liptruzet, is approved for the treatment of elevated LDL-cholesterol levels in patients with primary or mixed hyperlipidemia as an adjunct to dietary changes. (Source: theHeart.org)
Source: theHeart.org - May 3, 2013 Category: Cardiology Source Type: news
FDA Approves Combination Of Ezetimibe And Atorvastatin
The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - May 3, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
FDA approves Merck combination cholesterol lowering pill
(Reuters) - The U.S. Food and Drug Administration approved a Merck & Co cholesterol lowering pill that combines a generic version of Pfizer Inc's Lipitor with its own Zetia, Merck said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - May 3, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
FDA Approves Merck’s LIPTRUZET™ (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol
Dateline City:
WHITEHOUSE STATION, N.J.
LIPTRUZET Approved for Patients with Primary or Mixed Hyperlipidemia, as an Adjunct to Diet When Diet Alone Is Not Enough
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LIPTRUZET™(ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet w...
Source: Merck.com - Corporate News - May 3, 2013 Category: Pharmaceuticals Authors: Maria.tortoreto at merck.com Tags: Research and Development News Corporate News Latest News Source Type: news
Conference report: Niacin/laropripant combination (Tredaptive) associated with increased risk of bleeding and infections
Source: Reuters Health News
Area: News
Reuters Health News has reported that according to data presented at the annual American College of Cardiology scientific meeting, niacin in combination with laropripant (Tredaptive) was associated with statistically significantly higher rates of bleeding (2.5% vs 1.9%), and infections (8.0% vs 6.6%) compared to patients taking simvastatin or simvastatin/ezetimibe. They called the differences unexpected.
Additionally, patients taking Tredaptive also experienced higher rates of serious health problems that researchers said are known side effects of niacin, which included ne...
Source: NeLM - Cardiovascular Medicine - March 12, 2013 Category: Cardiology Source Type: news
High-stakes cholesterol study could lift Merck cloud
NEW YORK (Reuters) - Favorable results from a huge heart study could help redeem investors' faith in Merck & Co and its two biggest cholesterol drugs, Vytorin and Zetia, and potentially add billions of dollars in annual revenue. (Source: Reuters: Health)
Source: Reuters: Health - February 15, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
Appeals court upholds patent on Merck's Vytorin
WASHINGTON (Reuters) - A U.S. appeals court on Thursday ruled that the patent on Merck & Co's cholesterol fighter Zetia and a related drug, Vytorin, was valid. (Source: Reuters: Health)
Source: Reuters: Health - February 7, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
NICE publishes QIPP Medicines Management document
Source: NICE
Area: News
NICE has published an evidence based document summarising medicines management options for local implementation on identified topics supporting the QIPP medicines use and procurement work stream. The document, which is not formal NICE guidance, covers the following identified topics:
. Laxatives
. Renin-angiotensin system drugs
. Lipid modifying drugs including ezetimibe
. Omega-3 fatty acid supplements
. High dose inhaled corticosteroids in asthma
. Hypnotics
. Low dose antipsychotics in people with dementia
. First-choice ant...
Source: NeLM - News - February 1, 2013 Category: Drugs & Pharmacology Source Type: news
Merck Resubmits Data to FDA for Ezetimibe/Atorvastatin ComboMerck Resubmits Data to FDA for Ezetimibe/Atorvastatin Combo
The resubmission of the updated new drug application includes the additional data requested by the FDA, and the company expects the FDA review to be completed in the first half of 2013. Heartwire (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - January 9, 2013 Category: Consumer Health News Tags: Cardiology News Source Type: news
Merck resubmits data to FDA for ezetimibe/atorvastatin combo, again
The resubmission of the updated new drug application includes the additional data requested by the FDA, and the company expects the FDA review to be completed in the first half of 2013. (Source: theHeart.org)
Source: theHeart.org - January 8, 2013 Category: Cardiology Source Type: news
AWMSG publishes updated national prescribing indicators for 2013-2014
Source: All Wales Medicines Strategy Group (AWMSG)
Area: News
The All Wales Medicines Strategy Group (AWMSG) has endorsed revised National Prescribing Indicators for 2013-4, as set out in the document at the link below.
The indicators cover the following:
. Lipid-modifying drugs (items of low acquisition cost statins as a percentage of all statin, ezetimibe and simvastatin/ezetimibe combination prescribing)
. Hypnotics and anxiolytics (average daily quantity [ADQ] per 1,000 STAR-PUs)
. Dosulepin (defined daily dosage [DDD] per 1,000 PUs)
. Antidepressants (ADQ per 1,000 S...
Source: NeLM - News - January 7, 2013 Category: Drugs & Pharmacology Source Type: news
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
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
