Product News and Recalls

Drug-maker to resume atorvastatin sales in U.S. after recall

The Indian company Ranbaxy will resume production of its generic version of the anti-cholesterol drug Lipitor in the United States, according to a Reuters story.

The company had recalled the drug, called atorvastatin, in November after particles of glass were found in certain lots.

The original Lipitor, manufactured by Pfizer Inc., has also been the source of some safety concerns.

The U.S. Food and Drug Administration has added warnings to the labels of Lipitor and other variations of the widely used anti-cholesterol drugs called statins, warning that they may increase the risk of Type II diabetes. The new labels also warn that the drugs may raise blood sugar levels, and could cause memory loss.

Before Pfizer’s patent expired, Reuters reports, Lipitor was the world’s top selling prescription medicine, generating annual sales of about $13 billion.

According to the story, Ranbaxy has been under heightened regulatory scrutiny to ensure it meets good manufacturing practices after a series of manufacturing problems.

In 2008, the U.S. Food and Drug Administration prohibited the company from importing about 30 drugs after it found manufacturing deficiencies at two of the Ranbaxy’s facilities in India. The company was later accused of falsifying data used in its drug applications.

The story quotes a spokesman as saying that the company has “implemented multiple corrective and preventative actions.”

Patients should consult their doctors before making any changes in their medication. A consultation with a Lipitor lawyer is also important if there are significant injuries.

See the story here: