Dalal Street Investments

Lupin receives US FDA approval

July 17, 2007

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.


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