FDA Warns J&J Unit Over Joint Product Marketing

Law360, New York (August 25, 2010, 11:32 AM EDT) -- 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...
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