Lupin Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company'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(R) 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.
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are pleased with the approval of Amlodipine Besylate tablets." Ms. Gupta added, "This approval broadens our growing portfolio of cardiovascular medications, and we look forward to offering this cost-effective alternative to patients in the U.S."