Accessibility/Mobile Features
Skip Navigation
Skip to Content
Editorial News
Business
Classified Sites

The Canadian Press - ONLINE EDITION

Arbitration tribunal backs FDA in NAFTA dispute with generic drug firm Apotex

TORONTO - Generic drug company Apotex Inc. said Tuesday an arbitration tribunal has rejected its claims that the U.S. Food and Drug Administration violated the North American Free Trade Agreement by prohibiting imports of Apotex products from two Ontario plants for nearly two years.

Apotex president and chief executive Jeremy Desai said the company was disappointed by the decision.

"We remain strongly committed to the U.S. market and we continue to work closely with the FDA to resolve all outstanding issues and to achieve our shared objective of expanding the public's access to quality, affordable generic medicines," Desai said in a statement.

The U.S. Food and Drug Administration placed an import alert on two Apotex plants in Ontario on Aug. 28, 2009, that prevented the shipment of drugs they produced to the U.S.

The alert followed concerns raised by FDA inspections of the plants, however, Apotex accused the U.S. regulator of treating U.S. companies more favourably in similar circumstances.

A subsequent Health Canada inspection found manufacturing processes could be improved in ways that the company was addressing, but both plants were compliant. European, Australian and New Zealand regulators also followed the Health Canada determination.

The company said the two plants produced about 80 per cent of the products sold by Apotex's U.S. operations.

The import alert was lifted for the Etobicoke plant on June 15, 2011, while the alert applied to the Signet plant until July 29, 2011.

Apotex said the damages due to the alert totalled more than US$520 million because of the losses at its U.S. operations.

  • Rate this Rate This Star Icon
  • This article has not yet been rated.
  • We want you to tell us what you think of our articles. If the story moves you, compels you to act or tells you something you didn’t know, mark it high. If you thought it was well written, do the same. If it doesn’t meet your standards, mark it accordingly.

    You can also register and/or login to the site and join the conversation by leaving a comment.

    Rate it yourself by rolling over the stars and clicking when you reach your desired rating. We want you to tell us what you think of our articles. If the story moves you, compels you to act or tells you something you didn’t know, mark it high.

Sort by: Newest to Oldest | Oldest to Newest | Most Popular 0 Commentscomment icon

You can comment on most stories on brandonsun.com. You can also agree or disagree with other comments. All you need to do is register and/or login and you can join the conversation and give your feedback.

There are no comments at the moment. Be the first to post a comment below.

Post Your Commentcomment icon

Comment
  • You have characters left

The Brandon Sun does not necessarily endorse any of the views posted. Comments are moderated before publication. By submitting your comment, you agree to our Terms and Conditions. New to commenting? Check out our Frequently Asked Questions.

letters

Make text: Larger | Smaller

Brandon Sun Business Directory
The First World War at 100

Social Media

Canadian Mortgage Rates