Barr Pharmaceuticals, Inc. (NYSE: BRL) and its subsidiary PLIVA d.d. (LSE: PLVD; ZSE: PLVA-R-A) today announced that PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Pravastatin Tablets 10mg, 20mg, and 40mg, the generic version of Bristol-Myers Squibb’s PRAVACHOL(R) (Pravastatin Sodium) Tablets. The Company plans to launch its product immediately. PLIVA has also received tentative approval for its Pravastatin Tablets 80mg strength and plans to launch this strength following the expiration of a competitor’s 180-day generic drug exclusivity period and subsequent final approval of PLIVA’s application.
Pravastatin is indicated for the primary prevention of coronary events in hypercholesterolemic patients without clinically evident coronary heart disease, and secondary prevention of cardiovascular events in patients with clinically evident coronary heart disease. Pravastatin Tablets 10mg, 20mg and 40mg compete in a market that had total U.S. sales of approximately $1.2 billion, based on IMS data for the 12-month period ending September 2006.