Lupin has received approval from the US FDA for Abbreviated New Drug Application (ANDA) for Amlodipine Besylate tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). Commercial shipments of Amlodipine Besylate tablets will commence shortly.
The company’s Amlodipine Besylate tablets are AB-rated generic equivalent of Pfizer’s Norvasc tablets, a long-acting calcium channel blocker indicated for the treatment of hypertension. The brand product had annual sales of approximately $ 2.7 billion for the twelve months ended December 2006, based on IMS Health sales data.