FDA approves Teva's generic Pravachol

By Lisa Kerner

Erie, Pa., April 25 - The Food and Drug Administration granted final approval for Teva Pharmaceutical Industries Ltd.'s abbreviated New Drug Application to market the generic version of Bristol-Myers Squibb's Pravachol (Pravastatin Sodium) Tablets, 10 mg, 20 mg and 40 mg.

Shipment of these products will begin immediately, the company said.

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, according to a news release.

Teva's Pravastatin Sodium Tablets are indicated for the treatment of certain hyperlipidemias and the primary prevention of coronary events.

Annual brand product sales of the 10 mg, 20 mg and 40 mg strengths in the United States were about $1.5 billion for the 12 months ended Dec. 31.

The FDA's approval follows a U.S. Court of Appeals order dissolving an administrative injunction issued April 20 and denying Apotex's motion for injunctive relief pending appeal.

Teva is a generic pharmaceutical company based in Jerusalem, Israel.

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