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news.Barr Pharmaceuticals has said its subsidiary Pliva received final approval from the FDA for pravastatin tablets, the generic version of Bristol-Myers Squibb's Pravachol tablets for coronary events.
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Barr plans to market pravastatin tablets in 10mg, 20mg, and 40mg strengths and has received tentative approval for 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.
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 in 10mg, 20mg, and 40mg strengths had total US sales of approximately $1.2 billion, based on IMS data for the 12-month period ending September 2006.
Teva Pharmaceuticals was the first company to receive approval for a generic version of pravastatin from the FDA on April 24, 2006.