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Recent News and Articles on the Keywords: over-the-counter statin + over the + merck  Related to the article below (Last Update: 5/5/2008)

Merck could face tough 1Q on Vytorin, Singulair concerns
Forbes, NY - Apr 18, 2008
Early in the quarter, the FDA rejected Merck's application to sell the cholesterol drug Mevacor over the counter. Sales of the company's asthma and allergy ...MRK
Source: Google News

Consumer behavior in the setting of over-the-counter statin availability: Lessons from the Consumer … -
EP Brass - The American Journal of Cardiology, 2004 - Elsevier
... It has been suggested that the over-the-counter (OTC) availability of ... adherence to
an OTC regimen over the long ... to supervised care if the OTC statin did not ...

Reclassification of simvastatin to over-the-counter status in the United Kingdom: A primary … -
DB Nash, SA Nash - The American Journal of Cardiology, 2004 - Elsevier
... The United States over-the-counter statin model. ... Drug Administration (FDA) for OTC
Mevacor 20 mg (lovastatin; Johnson & Johnson ? Merck Consumer Pharmaceuticals ...

The liver and lovastatin -
KG Tolman - ACC Current Journal Review, 2002 - Elsevier
... In the hepatotoxicity files maintained by the FDA and MERCK, acute liver ... coronary
prevention and provides support to the over-the-counter statin advocates. ...

Move to sell statins over the counter raises concerns -
L Gibson - BMJ, 2004 - pubmedcentral.nih.gov
... next 10 years are eligible for statins on prescription. ... The over the counter product
is to be launched in ... Meanwhile, Merck is planning to refile an application ...

A Consumer Use Study of Over-the-Counter Lovastatin (CUSTOM) -
JM Melin, WE Struble, RW Tipping, JM Reynolds, TC … - The American Journal of Cardiology, 2004 - Elsevier
... the availability of an over-the-counter (OTC) statin. Lovastatin, the first marketed
statin, was approved in ... Users' behaviors were observed over the possible 26 ...

Physician?patient communication about over-the-counter medications -
B Sleath, RH Rubin, W Campbell, L Gwyther, T Clark - Social Science & Medicine, 2001 - Elsevier
... Society of Great Britain, and Merck, Sharp, and ... having more medications available
over-the-counter ( Rosenau & ... problematic if, for example, statin drugs become ...

[PDF] Over-the-counter statins: a new controversy -
J Abrams - Nature Clinical Practice Cardiovascular Medicine, 2005 - nature.com
... statins,when its National Health Service approved the pharmaceutical company Merck
Sharp & Dohme?s application to sell 10 mg simvastatin over the counter (OTC ...

Identifying patients with ischaemic heart disease in general practice: cross sectional study of … -
J Gray, A Majeed, S Kerry, G Rowlands - BMJ: British Medical Journal, 2000 - pubmedcentral.nih.gov
... Aspirin is cheaper to buy over the counter than on prescription ... strategy (aspirin,
atenolol, digoxin, and statins) can increase sensitivity to over 90 ...

The case for over-the-counter statins -
AM Gotto - The American Journal of Cardiology, 2004 - Elsevier
... in developing a program to provide over-the-counter (OTC) access ... the United Kingdom
to permit OTC statins makes the ... Merck heart drug set to go over counter in ...

Are OTC Statins Ready for Prime Time? -
M Mitka - JAMA, 2004 - Am Med Assoc
... grant from Johnson & Johnson-Merck to educate ... to take a position regarding OTC statin
products. ... a lot of potential good to over-the-counter statins," said Brown ...

Source: Google Scholar

Merck pushes for over-the-counter statin in US

Last Updated: 2007-12-13 13:53:49 -0400 (Reuters Health)

By Lisa Richwine

SILVER SPRING, Md. - Making a cholesterol drug available over the counter could give millions of Americans a new option to reduce the risk of heart disease and provide a major public health benefit, drugmaker Merck & Co Inc argued to a U.S. advisory panel on Thursday.

The company is making its third bid for U.S. approval to sell a low-dose, nonprescription version of its Mevacor cholesterol-lowering pill. Mevacor is one of the statin drugs taken by millions to cut cholesterol and the risk of heart disease, the leading killer of Americans.

Moving a statin over the counter would be a major shift. Nonprescription drugs generally treat short-term conditions with easy-to-recognize symptoms such as a headache or runny nose. High cholesterol can be detected only with a blood test, and statin treatment can last years.

The Food and Drug Administration is asking an advisory panel of outside experts to consider if patients can accurately decide for themselves if they are candidates for Mevacor.

The advisory panel is expected to vote later Thursday on whether to recommend approval for nonprescription Mevacor. The FDA will make the final decision but usually follows panel recommendations. Merck said an FDA ruling is expected in the first quarter of 2008.

An estimated 20 million Americans face moderate heart-disease risk and could benefit from a statin, yet just 6 million of them are on treatment, Merck officials said.

Having Mevacor available on drugstore shelves could lure many untreated patients to therapy, said Edwin Hemwall, an official with Merck Research Laboratories.

"Over time it will reduce the risk of a first heart attack and provide a real impact on public health," Hemwall said.

In a preliminary review released before the panel meeting, FDA reviewers questioned Merck's studies of patients who read the drug's proposed label and decided if they should try Mevacor.

In one study, about 30 percent of people with diabetes or a history of heart disease or a stroke wanted to buy Mevacor, FDA reviewers said. The label advised such patients to consult a doctor before use.

GlaxoSmithKline PLC recently acquired exclusive U.S. rights to sell over-the-counter Mevacor in return for undisclosed milestone and royalty payments to Merck.

Prescription Mevacor, known generically as lovastatin, debuted on the U.S. market in 1987. The drug lost patent protection in 2001. An over-the-counter version would receive three years of exclusive marketing time before generic competition could begin.

Copyright © 2007 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

 
 
 
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