FDA Warns J&J Unit Over Joint Product Marketing

Law360, New York (August 25, 2010, 11:32 AM ET) -- The U.S. Food and Drug Administration has warned Johnson & Johnson's DePuy Orthopaedics Inc. unit that two of its artificial joint products are being sold without required marketing approval and clearance.

In a letter to DePuy dated Aug. 19 and widely reported Tuesday, the FDA claims that the company's Corail Hip System is being marketed in the U.S. for off-label uses.

The letter from Timothy A. Ulatowski, director of the FDA's compliance office for the Center for Devices and Radiological Health, orders DePuy to immediately stop...
To view the full article, take a free trial now.

Already a subscriber? Click here to login

Already have access?

  1. Forgot your password?
  2. Sign In

Get instant access to the one-stop news source for business lawyers

Required