Content about Simvastatin

May 6, 2013

The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

Merck announced the approval of Liptruzet (ezetimibe and atorvastatin). The drug combines two preexisting cholesterol drugs: ezetimibe, which Merck markets under the brand name Zetia, and atorvastatin, which Pfizer markets under the name Lipitor. Both drugs are available as generics, but because Liptruzet is a novel combination of them, it required FDA approval as a new drug.

June 21, 2012

It’s been cited as one of the biggest health crises facing the United States and, if solved, the equivalent dollar value of a blockbuster drug. According to the latest statistics from pharmacy benefit manager Express Scripts, poor medication adherence costs the country $317 billion per year, an upgrade from the $290 billion calculated in a study released in 2009 by the New England Healthcare Institute.


It’s been cited as one of the biggest health crises facing the United States and, if solved, the equivalent dollar value of a blockbuster drug. According to the latest statistics from pharmacy benefit manager Express Scripts, poor medication adherence costs the country $317 billion per year, an upgrade from the $290 billion calculated in a study released in 2009 by the New England Healthcare Institute.


May 23, 2012

Food and Drug Administration drug warnings can have an immediate negative impact on medication adherence among patients, even if the warnings are not safety related, according to new research sponsored by CVS Caremark.

WOONSOCKET, R.I. — Food and Drug Administration drug warnings can have an immediate negative impact on medication adherence among patients, even if the warnings are not safety related, according to new research sponsored by CVS Caremark.

April 30, 2012

Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

WHITEHOUSE STATION, N.J. — Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

Merck said the U.S. District Court for the District of New Jersey ruled against Mylan in two patent infringement suits related to the drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin). Specifically, the court ruled that a patent covering the drug, RE 42,461, is valid and enforceable and enjoined Mylan from launching until the patents expiration in April 2017.

March 6, 2012

The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.

October 7, 2011

The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

The FDA approved Merck's Juvisync (sitagliptin and simvastatin), manufactured by Merck subsidiary MSD International GmbH Clonmel Co., based in Tipperary, Ireland. Merck operates under the name MSD outside the United States and Canada in order to avoid confusion with Germany-based Merck KGaA.

June 9, 2011

The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

May 20, 2011

A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.

ABBOTT PARK, Ill. — A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met Thursday to discuss whether to recommend continued FDA approval of Trilipix (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia and a high risk of heart disease. The FDA is not bound by advisory committee votes, but usually follows them.

May 17, 2011

A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

SILVER SPRING, Md. — A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

November 29, 2010

Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.

November 21, 2010

A cholesterol-lowering drug made by Merck appears to reduce the risk of heart attacks, strokes...

DENVER A cholesterol-lowering drug made by Merck appears to reduce the risk of heart attacks, strokes and cardiac death in patients with chronic kidney disease, according to results of a new study.

 

Merck said results of a 9,000-patient clinical study showed that Vytorin (ezetimibe and simvastatin) reduced the risks by 16.1% compared with placebo. Results of the study were presented Saturday at the annual meeting of the American Society of Nephrology.

 

 

August 23, 2010

Drug advertisements that tie disease risks with family history can influence consumers' choice of medications...

PHILADELPHIA Drug advertisements that tie disease risks with family history can influence consumers' choice of medications and have a beneficial effect on those consumers' lifestyle choices, according to a study published in the August issue of the Journal of Applied Communication Research.

 

August 23, 2010

Generic drug maker Impax Labs is hoping to win approval for a generic cholesterol-lowering drug....

August 1, 2010

Merck had global sales of $11.3 billion and profits of $752 million during second quarter...

July 18, 2010

Metabolex has entered an agreement to discover and develop Type 2 diabetes drugs with a...

July 8, 2010

CVS Caremark made a major push to showcase the tools it uses to curb costs...

WHAT IT MEANS AND WHY IT'S IMPORTANT CVS Caremark made a major push to showcase the tools it uses to curb costs as it revealed a study indicating that more lax generic regulations could save states millions of dollars, not to mention that its annual insights report revealed an increase in generic dispensing rates.

(THE NEWS: CVS Caremark study: Less restrictive generic laws could curb state Medicaid costs. For the full story, click here)

July 6, 2010

Changing generic substitution laws in favor of less-restrictive regulations could save states struggling to pay...

WOONSOCKET, R.I. Changing generic substitution laws in favor of less-restrictive regulations could save states struggling to pay for increasing healthcare costs through their Medicaid programs more than $100 million over the next several years, according to a new CVS Caremark study.

June 17, 2010

The Food and Drug Administration has approved a generic cholesterol medication made by Mylan, the...

May 4, 2010

A subsidiary of Watson Pharmaceuticals is challenging the patent to a drug for high cholesterol,...

March 21, 2010

Merck & Co. has responded to a warning by the Food and Drug Administration about...

March 18, 2010

Patients taking a common drug for treating high cholesterol may be at increased risk of...