US FDA has granted approval to Lupin for for Amlodipine Besylate Tablets indicated for the treatment of hypertension
Lupin limited, has received approval from the US FDA for it’s 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. Lupin’s Amlodipine Besylate Tablets are the 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.
According to Dr. Kamal Sharma, Managing Director this approval broadens the company’s growing portfolio of cardiovascular medications.