US FDA approves Ranbaxy''s pravastatin sodium tablets

The US FDA has approved Ranbaxy Laboratories'' cholesterol lowering drug pravastatin sodium tablets in 10mg, 20mg, 40mg and 80mg dosages for to manufacture and marketing in the US. The 80mg tablets have been granted 180-day market exclusivity in the US.

Ranbaxy says its formulation has been found to be bio equivalent and, therefore, therapeutically equivalent to the reference-listed drug Pravachol manufactured by Bristol Myers Squibb.

The total annual market for all pravastatin products in the US was $1.19 billion (IMS - MAT: December 2006), with the annual sales for 80mg alone having been $209 million (IMS: MAT - December 2006).

Pravastatin is among the most studied statins used for managing high levels of low-density lipoprotein, which leads to premature atherosclerosis of the coronary arteries.

Statins reduce cholesterol by inhibiting the enzyme HMG-CoA reductase in the liver that is necessary for the production of cholesterol. In the blood, statins lower total and low-density lipoproteins or the bad cholesterol as well as triglycerides.

They also increase high-density lipoproteins, or the good cholesterol. LDL cholesterol is believed to be an important cause of coronary artery disease. Lowering LDL cholesterol levels slows and may even reverse coronary artery disease. Raising HDL cholesterol levels also may slow coronary artery disease.

According to the company pravastatin is also used to reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularisation procedures and reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.

It is also indicated for treatment in the secondary prevention of cardiovascular events such as in patients with clinically evident coronary heart disease to reduce the risk of stroke and stroke / transient ischemic attack (TIA), and slow the progression of coronary atherosclerosis.

According to Jim Meehan, vice president, sales and marketing, Ranbaxy Pharmaceutical Inc, the pravastatin will be manufactured at its subsidiary Ohm Laboratories in New Brunswick.