TEVA GETS APPROVAL FOR GENERIC ZOCOR

Israel-based Teva has announced that the U.S. FDA has granted tentative approval for its abbreviated new drug application (ANDA) for Simvastatin tablets -- the generic equivalent of Merck's Zocor.

Teva is the first company to apply to market the product in low strengths (5-40 mg.), and will therefore be entitled to 180 days marketing exclusivity, said the company.

The U.S. FDA has filed an appeal to the U.S. Court of Appeals concerning Teva's 180-day exclusivity. Teva expects to receive final approval for the 5 mg, 10 mg, 20 mg, and 40 mg strengths with exclusivity on June 23, when the product patent expires.