180-day US exclusivity for Ranbaxy's Pravastatin

Ranbaxy Laboratories has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Pravastatin Sodium tablets (Pravastatin), 10 mg, 20 mg, 40 mg and 80 mg with 180-day exclusivity for the 80 mg dosage.

According to a release issued by Ranbaxy to the BSE today, the Office of Generic Drugs, USFDA has determined the company's formulation to be bioequivalent and therefore therapeutically equivalent to the reference listed drug Pravachol from Bristol Myers Squibb. Total annual sales for all strengths was $1.19 billion, and the annual sales for 80mg alone is $209 million, the release added.

Pravastatin is indicated in the treatment of primary prevention of coronary events such as in hypercholesterolemic patients without clinically evident coronary heart disease. Pravastatin is also indicated to reduce the risk of myocardial infarction, reduce the risk of undergoing myocardial revascularization procedures and reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes, the release added.