Teva gets first FDA approval for generic Pravachol

Israel's Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted final approval for its Abbreviated New Drug Application to market its generic version of Bristol-Myers Squibb's Pravachol (pravastatin sodium) tablets, 10mg, 20mg and 40mg. Shipment of these products will begin immediately. As the first company to file an ANDA containing a paragraph IV certification for these strengths, Teva has been awarded 180 days of marketing exclusivity.

Pravastatin is indicated for the treatment of certain hyperlipidemias and the primary prevention of coronary events. Annual brand product sales in the USA of the three dosage strengths were approximately $1.5 billion for the 12 months ended December 2005.

The April 25 approval follows an order by the US Court of Appeals for the DC Circuit dissolving an administrative injunction issued April 20, and denying Apotex' motion for injunctive relief pending appeal, says Teva.