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FDA Warns Drug Makers to Stop Selling Unapproved Prescription Painkillers
Date:3/31/2009

t Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.

The market share of these unapproved pain products varies from product to product. One product slated to be removed from the market has about a 4 percent market share, while another unapproved product represents about 53 percent of the market, Autor said.

"Today's action is about ensuring that Americans have safe and effective drugs and getting the message to companies that they have a responsibility to patients that they should actively pursue FDA approval for their illegally marketed products," Autor said.

The FDA's pursuit of unapproved drugs began in 2006, and to date the agency's action has taken more than 500 unapproved drugs off the market from over 200 drug companies, Autor said. There are still several thousand unapproved drugs on the market, she added.

More information

For more on unapproved drugs, visit the U.S. Food and Drug Administration.



SOURCES: March 31, 2009, teleconference with Deborah Autor, J.D., director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.


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