FDA Warns 9 Firms For Illegally Making Narcotics
March 31 2009 - 12:24PM
Dow Jones News
The Food and Drug Administration on Tuesday warned nine
companies for illegally making powerful prescription drugs used to
treat severe pain.
The FDA said the companies should stop manufacturing the
products within 60 days if they want to avoid further enforcement
action. The FDA sent the warnings to Xanodyne Pharmaceuticals Inc.,
Cody Laboratories Inc. and Mallinckrodt Inc. Pharmaceuticals Group,
a unit of Covidien Ltd. (COV), among others.
The drugs involved contain morphine, a powerful painkiller, and
hydromorphone or oxycodone. The FDA's move doesn't relate to
approved versions that contain these ingredients, said Deborah
Autor, director of the office of compliance within the drug
division of the agency.
Tuesday's announcement is part of a broader investigation by the
FDA to keep unapproved drugs off the market. Since the FDA began in
2006 to keep unapproved products off the market, the agency has
targeted more than 200 companies and 500 products, Autor said.
"It is a high priority for the FDA to remove these products from
the market because they may be unsafe, ineffective, inappropriately
labeled, or of poor quality," said Janet Woodcock, an FDA director,
in a statement.
The FDA said the announcement won't result in drug shortages for
people who need to take the pain medicines, as there is adequate
approved versions of these drugs on the market.
The FDA said consumers concerned about whether they are taking
unapproved versions of these drugs should contact their physician
and consult the FDA's unapproved drugs Web site at
http://www.fda.gov/cder/drug/unapproved_drugs/.
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207;
jared.favole@dowjones.com