FDA grants Teva generic Pravachol marketing approval
Just days after Bristol-Myers Squibb’s patent for its cholesterol-lowering blockbuster Pravachol (pravastatin sodium tablets) expired on April 20, the FDA announced its approval of Teva Pharmaceuticals’ generic version of the drug.
Teva has also been granted 180 days of marketing exclusivity of generic pravastatin.
“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 Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, in a statement. “Pravastatin is a widely used cholesterol-lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease.”
In 2005, Pravachol was the 22nd-highest-selling brand-name drug in the US, with sales totaling $1.3 billion.
Bristol-Myers Squibb said in a statement, “Anticipated sales declines due to continued exclusivity losses during 2006 are expected to be more or less offset by growth in sales of the company’s growth drivers and potential new products.”