Final FDA approval for Ranbaxy's amlodipine

15 July 2007

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight