Teva Gets FDA Approval for Generic Norvasc
July 3, 2007
Teva Pharmaceutical Industries has been granted FDA approval for its amlodipine besylate tablets for the treatment of chronic stable angina and vasospastic angina.
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.