FDA OK’s Generic Pravachol

The Food and Drug Administration said Monday it has approved the first generic version of Bristol-Myers Squibb’s Pravachol.

The drug, pravastatin sodium tablets, is indicated for the treatment of high cholesterol levels or for patients who are at heightened risk for atherosclerosis-related cardiac and cardiovascular events, including heart attack and stroke where high cholesterol levels are a factor, the agency said.

Pravachol had sales of $1.3 million last year, making it the 22nd highest-selling brand-name drug in the United States, FDA said.

This approval is another example of our agency’s endeavor to counter rising healthcare costs by approving safe and effective generic alternatives as soon as the law permits, said Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs.

More than half of all prescriptions are filled with generic drugs, the agency said.