Lupin Ltd has received approval from the US FDA for it's abbreviated new drug application (ANDA) for Amlodipine Besylate tablets, 2.5 mg, 5 mg and 10 mg.
According to a company press release, the 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.
"We are pleased with the approval of Amlodipine Besylate tablets. This approval broadens our growing portfolio of cardiovascular medications," said Dr Kamal Sharma, managing director, Lupin.