FDA Approves Generic Lipitor; Will Be Marketed By Ranbaxy

The U.S. Food and Drug Administration Wednesday approved the first generic version of Pfizer Inc.'s (PFE) cholesterol-lowering drug Lipitor.

Earlier Wednesday Watson Pharmaceuticals Inc. (WPI) began selling a generic version of Lipitor, marking the long-awaited loss of U.S. market exclusivity for the world's top-selling drug. Watson, of Parsippany, N.J., is selling a so-called authorized generic version of Lipitor, in partnership with Pfizer. The deal runs until November 2016.

The agency said Ranbaxy Laboratories Ltd., a unit of Japan's Daiichi Sankyo Co., (4568.TO) gained approval to make generic atorvastatin calcium tablets in four strengths ranging from 10 to 80 milligrams.

FDA said the drug will be manufactured by Ohm Laboratories in New Brunswick, N.J.

Under the federal law authorizing generic drugs, Ranbaxy was given first dibs on selling a no-name version of Lipitor for 180 days because it was the first to apply for FDA approval, submitting a request in 2002.

In 2008, Ranbaxy reached agreement with Pfizer allowing for sales to start Nov. 30. Yet it was unclear whether the FDA would grant approval, given the manufacturing problems the agency had found at the company. The FDA accused a Ranbaxy plant in India of submitting false and unreliable data.

Cholesterol-lowering drugs like Lipitor work to lower low-density lipoprotein, or LDL, cholesterol often referred to as "bad" cholesterol. High cholesterol increases the likelihood of developing heart disease and other cardiovascular-related conditions.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]