The US Food and Drug Administration has granted tentative approval for the Teva Pharmaceuticals' ANDA for simvastatin tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.
Upon final approval, Teva's simvastatin tablets will be the AB-rated generic equivalent of Merck's Zocor tablets, a product indicated for the treatment of high cholesterol, states a company release.
The brand product has annual sales of approximately $4.4 billion.
Teva Pharmaceutical Industries Ltd. is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.