FDA OKs Generic Version of Pravachol
Pravastatin Is First Generic Version of This Cholesterol-Lowering Drug, FDA Says
April 25, 2006 -- The FDA has approved the first generic version of Bristol-Myers Squibb's Pravachol (pravastatin).
Pravastatin is used to treat high cholesterol levels (hyperlipidemia) and to help prevent heart attacks and strokes in which high cholesterol levels could be a factor. It's in the class of drugs called "statins," which includes Zocor, Lipitor, and others.
In 2005, Pravachol was the 22nd best-selling brand-name drug in the U.S., with sales totaling $1.3 billion, states an FDA news release.
According to the FDA, Bristol-Myers Squibb's patent for the drug expired on April 20. Generic pravastatin tablets (10 milligrams, 20 milligrams, and 40 milligrams) are manufactured by TEVA Pharmaceuticals in Kfar Sava, Israel.
Generic Drugs Popular
The FDA news release calls the approval of generic pravastatin "an important step in the agency's effort to increase the availability of lower-cost generic medications."
"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," says Scott Gottlieb, MD, FDA deputy commissioner for medical and scientific affairs, in the FDA's news release.
"Pravastatin is a widely used cholesterol-lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease," Gottlieb continues.
Generic drug products are used to fill more than 50% of all prescriptions, and since they cost a fraction of the price of brand-name drugs, the economic impact of the FDA's generic drug program is "profound," states the FDA.
The FDA notes that its Office of Generic Drugs "continues to work expeditiously to review and take action on generic drug applications as quickly as possible" and is taking steps to improve that process.