The Croatia-based Pliva, the subsidiary of the New Jersey-based Barr Pharmaceuticals Inc, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market pravastatin tablets 10 mg, 20 mg, and 40 mg, the generic version of Bristol-Myers Squibb's Pravachol (pravastatin sodium) tablets. The company plans to launch these products soon.
Pliva has also received tentative approval for its pravastatin tablets 80 mg 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, the company stated.
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 10 mg, 20 mg and 40 mg compete in market that had total US sales of approximately $1.2 billion, based on IMS data for the 12-month period ended on September 2006.
Barr is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.
A holding company, Barr operates through its principal subsidiaries: Barr Laboratories Inc, Duramed Pharmaceuticals Inc and Pliva and its subsidiaries. The company markets more than 120 generic and 25 proprietary products in the US and more than 550 products globally outside of the US Barr has acquired Pliva recently.