The approval covers the drug in 2.5mg, 5mg and 10mg doses. Shipment of the product will begin shortly.
Teva’s tablets are the AB-rated generic equivalent of Pfizer’s Norvasc tablets. Mylan, which also markets a generic version, has sued the FDA arguing that its 180-day exclusivity blocks other final approvals until September, 2007.
Total annual sales of the drug are approximately $2.8 billion for the 12 months ended March 31, 2007, based on IMS sales data.