Ranbaxy gets FDA nod for Norvasc generic

Ranbaxy Laboratories, the country's largest pharmaceutical company, has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market amlodipine besylate tablets in 2.5 mg (base), 5 mg (base) and 10 mg (base).

The 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 Norvasc tablets of Pfizer Pharmaceuticals. The total annual market sales for Norvasc is $2.79 billion.

Amlodipine besylate tablets are prescribed for the treatment of hypertension and may be used alone or in combination with other anti-hypertensive agents.

The tablets are given for the symptomatic treatment of chronic stable angina and confirmed or suspected vasospastic angina.

"We are pleased to receive this final FDA approval for amlodipine besylate tablets, which represents Ranbaxy's 115th abbreviated new drug application (ANDA) approval to date. This product will further expand our product portfolio of affordable generic alternatives and will be launched in August 2007 to all classes of trade," said Jim Meehan, vice-president, sales and marketing, Ranbaxy Pharmaceuticals Inc, US.

Ranbaxy Pharmaceuticals Inc (RPI), based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories.

RPI is engaged in the sales and distribution of generic and branded prescription products in the US healthcare system.