Final FDA approval for Ranbaxy's amlodipine

Ranbaxy Pharmaceuticals, the US subsidiary of India's Ranbaxy group, has received final approval from the Food and Drug Administration to manufacture and market amlodipine besylate tablets, 2.5mg (base), 5mg (base) and 10mg (base). The agency's Office of Generic Drugs has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug, Pfizer's Norvasc.

Total annual US market sales for Norvasc, indicated for the treatment of hypertension, were $2.79 billion in the 12 months to March, says Ranbaxy, quoting IMS Health figures.

The FDA clearance of its generic amlodipine represents Ranbaxy's 115th Abbreviated New Drug Application approval to date, the company noted. It will be launched in August to all classes of trade, said Jim Meehan, vice president of sales and marketing for Ranbaxy in the USA.