The Canadian Press - ONLINE EDITION

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

  • Print

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.

Fact Check

Fact Check

Have you found an error, or know of something we’ve missed in one of our stories?
Please use the form below and let us know.

* Required
  • Please post the headline of the story or the title of the video with the error.

  • Please post exactly what was wrong with the story.

  • Please indicate your source for the correct information.

  • Yes

    No

  • This will only be used to contact you if we have a question about your submission, it will not be used to identify you or be published.

  • Cancel

Having problems with the form?

Contact Us Directly
  • Print

You can comment on most stories on winnipegfreepress.com. You can also agree or disagree with other comments. All you need to do is be a Winnipeg Free Press print or e-edition subscriber to join the conversation and give your feedback.

You can comment on most stories on winnipegfreepress.com. You can also agree or disagree with other comments. All you need to do is be a Winnipeg Free Press print or e-edition subscriber to join the conversation and give your feedback.

Have Your Say

New to commenting? Check out our Frequently Asked Questions.

Have Your Say

Comments are open to Winnipeg Free Press print or e-edition subscribers only. why?

Have Your Say

Comments are open to Winnipeg Free Press Subscribers only. why?

The Winnipeg Free Press does not necessarily endorse any of the views posted. By submitting your comment, you agree to our Terms and Conditions. These terms were revised effective April 16, 2010.

letters

Make text: Larger | Smaller

LATEST VIDEO

Reimagining Winnipeg as the big city of the future

View more like this

Photo Store Gallery

  • Challenges of Life- Goose Goslings jump over railway tracks to catch up to their parents at the Canadian Pacific Railway terminalon Keewatin St in Winnipeg Thursday morning. The young goslings seem to normally hatch in the truck yard a few weeks before others in town- Standup photo- ( Day 4 of Bryksa’s 30 day goose project) - Apr 30, 2012   (JOE BRYKSA / WINNIPEG FREE PRESS)
  • JOE.BRYKSA@FREEPRESS.MB.CA Local-(Standup photo)- Humming Around- A female ruby -throated hummingbird fly's through the bee bomb  flowers Friday at the Assiniboine Park English Garden- Nectar from flowers are their main source of food. Hummingbirds wings can beat as fast as 75x times second. Better get a glimpse of them soon the birds fly far south for the winter - from Mexico to South America- JOE BRYKSA/WINNIPEG FREE PRESS- Sept 10, 2009

View More Gallery Photos

Poll

Do you support Canada's involvement in the fight against Islamic State?

View Results

View Related Story

Ads by Google