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FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets
Date:10/13/2009

utors have 180 days to cease further shipment of existing products. Previously manufactured unapproved products may still be found on pharmacy shelves for a period of time.

Today's action is part of the FDA's initiative against the marketing of unapproved drugs, announced in June 2006. At that time, the agency published a Compliance Policy Guide describing the FDA's risk-based enforcement approach to unapproved products.

"Doctors and patients often find that some drugs on the market do not have FDA approval," said Deborah M. Autor, director of CDER's Office of Compliance. "This lack of approval undermines the FDA's process to ensure that safe and effective drugs are available to the U.S. public."

Consumers who rely on opioid analgesics for pain relief have access to products that have been evaluated by the FDA and determined to be safe and effective for use. There are other FDA-approved drugs, including different opioid analgesics, which can be used to relieve pain. Consumers should consult a health care professional for detailed guidance on treatment options.

For additional information, including copies of the warning letters that identify the firms involved and the names of their products, see the FDA's Unapproved Drugs Web page/Enforcement Actions, located at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118712.htm

For more information

Drugs Marketed in the United States That Do Not Have Required FDA Approval

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformat
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SOURCE U.S. Food and Drug Administration
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