FDA Halts Marketing of Unapproved Codeine Sulfate Tablets

The FDA has warned four companies that they must stop marketing unapproved codeine sulfate tablets.
These drugs are opioid analgesics, commonly called narcotics, widely used to treat pain.

These particular products have not received FDA approval, and the agency has no evidence they are safe and effective. Roxane Laboratories markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets.

"Consumers deserve and expect that their drugs meet modern FDA standards for safety, effectiveness, labeling and quality. Removing unapproved products that do not meet those standards is an FDA priority," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research (CDER). "The FDA urges drug companies to ensure all drugs they make and market have appropriate FDA approval."

These are the products and their manufacturers and distributors that received warning letters:

• Codeine sulfate tablets, 30 mg, 60 mg -- Lehigh Valley Technologies Inc.
• Codeine sulfate tablets, 30 mg, 60 mg -- Cerovene Inc.
• Codeine sulfate tablets, 30 mg -- Dava International Inc.
• Codeine sulfate tablets, 30 mg, 60 mg -- Glenmark Generics Inc. USA

These companies have 15 days to give the FDA a plan to discontinue marketing the unapproved drugs. Manufacturers have 90 days to cease making new product, and distributors 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.

This 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 about unapproved drugs, including copies of the warning letters that identify the firms involved and the names of their products, see the FDA's Unapproved Drugs/Enforcement Actions Web site. More information about drugs available in the U.S. can be found at these FDA Web sites:

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

Contact:
Chris Kelly
301-796-4676
christopher.kelly@fda.hhs.gov