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FDA Approves Generic Version Of Cholesterol Drug

By Mark Huffman
ConsumerAffairs.com

April 25, 2006

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The Food and Drug Administration has approved the first generic version of Bristol-Myers Squibb's Pravachol, a move it touts as an important step in the agency's effort to increase the availability of lower-cost generic medications.

Pravachol (Pravastatin Sodium Tablets) is indicated for the treatment of individuals with high cholesterol levels or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke in which high cholesterol levels are a factor.

In 2005, Pravachol was the 22nd highest-selling brand-name drug in the United States, with sales totaling $1.3 billion.

"This approval is another example of our agency's endeavor to counter rising health care costs by approving safe and effective generic alternatives as soon as the law permits," said Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs.

"Pravastatin is a widely-used cholesterol-lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease."

Generic drug products are used to fill over 50 percent of all prescriptions and since they cost a fraction of the price of brand name drugs, the economic impact of FDA's generic drug program is significant.

FDA's Office of Generic Drugs (OGD) said it is considering several new policies that could lead to the overall reduction of review time for new generics.

These include new review formats which allow for overall risk assessments for individual applications in order to dictate the level of OGD review need for subsequent product changes. When fully implemented this has the potential to reduce supplements by 80 percent and reduce Office expenditures of time and money.

Bristol-Myers Squibb's patent for the drug expired on April 20. Pravastatin Sodium Tablets (10mg, 20mg and 40mg) are manufactured by TEVA Pharmaceuticals in Kfar Sava, Israel.

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