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Merck Receives Complete Response Letter from the U.S. FDA for ZETIA (ezetimibe) and VYTORIN (ezetimibe and simvastatin)

2016-02-15 23:30:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KENILWORTH, 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 issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for ZETIA and VYTORIN for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease. Language: English Contact: MerckMedia:Pam Eisele, 267-305-3558orMichael Close, 267-305-1211orInvestors:Amy Klug, 908-740-1898orTeri Loxam, 908-740-1986 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Merck Statement on FDA Advisory Committee Meeting on IMPROVE-IT Study with VYTORIN (ezetimibe and simvastatin)

2015-12-15 00:23:15| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. Merck (NYSE: MRK), known as MSD outside the United States and Canada, issued today the following statement after the conclusion of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss the results of IMPROVE-IT, an investigational study comparing treatment with VYTORIN (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes. Language: English read more

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New Analyses from the IMPROVE-IT Study with VYTORIN (ezetimibe and simvastatin)

2015-09-01 15:00:00| Merck.com - Research & Development News

Dateline City: KENILWORTH, N.J. Further Analyses on the Long-Term Safety and Efficacy of VYTORIN from the IMPROVE-IT Study Presented at the European Society of Cardiology (ESC) Meeting KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD in the United States and Canada, today announced results from new analyses from the IMPROVE-IT study. IMPROVE-IT presents us with the opportunity to look at cardiovascular outcomes data for patients treated with the combination of simvastatin and ezetimibe (VYTORIN) and allows us to look at the important aspect of long-term safety and efficacy under controlled conditions, said Dr. Michael A. Blazing, Duke Department of Medicine. Language: English Contact: For MerckMedia:Pamela Eisele, 267-305-3558orMichael Close, 267-305-1211orInvestors:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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New Analyses from the IMPROVE-IT Outcomes Study of VYTORIN (ezetimibe and simvastatin) and the TECOS Cardiovascular Safety Trial of JANUVIA (sitagliptin) Will Be Presented at the European Society of Cardiology Congress

2015-08-20 14:30:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. Additional Real-World Analyses from DYSIS and DYSIS II Assessing the Treatment of Dyslipidemia to be Presented KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that new analyses from the investigational IMPROVE-IT (IMProved Reduction of Outcomes: VYTORIN Efficacy International Trial) study of VYTORIN (ezetimibe and simvastatin), the TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) cardiovascular safety trial of JANUVIA (sitagliptin), and real-world data from the Dyslipidemia International Study (DYSIS I and DYSIS II) will be presented at the upcoming European Socie Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orKim Hamilton, 908-391-0131orInvestor:Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Results from Investigational IMPROVE-IT Study of VYTORIN (ezetimibe and simvastatin) Published in the New England Journal of Medicine

2015-06-03 23:00:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New England Journal of Medicine published the results of the IMPROVE-IT trial, an investigational study comparing treatment with VYTORIN (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes. Language: English Contact: MerckMedia:Pamela Eisele, (267) 305-3558Tracy Ogden, (267) 305-2301orInvestor:Justin Holko, (908) 740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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