UK Approves OTC Status For Statins

From: art fougner, md (evsono@pipeline.com)
Wed May 12 14:17:17 2004


Britain to Approve Cholesterol Drugs For OTC Sale

REUTERS NEWS SERVICE May 11, 2004; Page D5

LONDON -- Statin drugs, widely taken to cut cholesterol and reduce the risk of heart attacks, are set to be approved for sale in Britain without a doctor's prescription.

The move would make Britain the first country in the world to sell statins over the counter. Experts recommended last year that pharmacists should be able to supply them without a prescription following simple health checks carried out on the spot. An advisory panel to the U.S. Food and Drug Administration may consider data in support of allowing nonprescription sales of statins within the next year.

"There will be an announcement on Thursday," said a spokeswoman for Britain's department of health, following weekend reports that Health Secretary John Reid was about to give a green light to over-the-counter sales of the drugs.

Merck & Co.'s Zocor, generically called simvastatin, will be the first cholesterol fighter to be sold over the counter, in doses of 10 milligrams. Zocor was once Merck's top-selling product, but it lost patent protection in Britain last year, and the company, based in Whitehouse Station, N.J., is eager to make up for lost sales by switching into the nonprescription market.

McNeil Europe, a unit of Johnson & Johnson that specializes in European OTC drugs, is expected to launch Zocor Heart-Pro -- as the product will be known -- at the end of June or early July. It will be priced between £10 and £15 (about $18 to $27) per 28-day pack.

The company said it was still waiting for the formal license but had been preparing for the launch for several months. In the U.S., a joint venture of Merck and Johnson & Johnson, based in New Brunswick, N.J., is hoping to eventually sell its Mevacor statin without a prescription.

The British government has said that it would like pharmaceutical companies to apply for the right to sell statins without a prescription -- a move that could reduce the state's drug bill.

Currently some 1.5 million Britons receive statin therapy and the National Health Service spends around £750 million on the drugs each year.

Statins are among the most widely prescribed of all medicines, with Pfizer Inc.'s market leader Lipitor generating world-wide sales of $9.23 billion in 2003.

http://online.wsj.com/article/0,,SB108423039777807478,00.html?mod=health%5Fhome%5Fstories

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art fougner, md
ich bin ein New Yorker




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