Pfizer Ponders OTC Lipitor

Cholesterol drug Lipitor could soon be sold without a prescription

(RxWiki News) Drug maker Pfizer is contemplating an over-the-counter version of its cholesterol drug Lipitor, The Wall Street Journal has reported, citing sources familiar with the effort.

The drug is one of the world's best selling drugs, and the move is suspected to be tied to its patent loss in November, which will allow other companies to make and sell generic versions of the medication.

"Continue taking cholesterol drugs recommended by your doctor."

A version that would be available without a prescription would allow the company to hold onto the $11 billion in annual revenue it has been generating from sales of Lipitor.

It might prove too large of a hurdle though. The U.S. Food and Drug Administration has previously declined to approve over-the-counter versions of other cholesterol medications. Merck was turned down three times when it tried to get cholesterol drug Mevacor approved. Like Lipitor, Mevacor is a statin. Bristol-Myers-Squibb also was unable to get its statin approved.

In order to gain approval the drug maker would have to convince FDA officials that patients could safely take the drug without physician oversight. The FDA has previously been concerned over the prospect of over-the-counter statins, since those who did not need them also could take them.

Pfizer has not confirmed or denied The Wall Street Journal report, which also mentioned that a branded generic version may be another option.

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Review Date: 
August 8, 2011