Barr's Pliva unit approval for generic pravastatin

Barr Pharmaceuticals says that its recently-acquired Croatian subsidiary Pliva (Marketletters passim) has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application to manufacture and market pravastatin tablets 10mg, 20mg, and 40mg, the generic version of Bristol-Myers Squibb's Pravachol. The company plans to launch its product immediately. Pliva has also received tentative approval for its pravastatin 80mg and plans to introduce this strength following the expiration of a competitor's 180-day generic drug exclusivity period and subsequent final approval.

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. The 10mg, 20mg and 40mg tablets compete in a market that had total US sales of around $1.2 billion, based on IMS data for the 12-month period ending September.