FDA NEWS RELEASE

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FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets

Four Companies Required to Stop Making and Distributing Illegal Opioid Pain Relievers

The U.S. Food and Drug Administration today warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain.

These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, 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, M.D., 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.”

The names of the products and the manufacturers and distributors that received the warning letters are:

Lehigh Valley Technologies Inc., Allentown, Penn.
Cerovene Inc., Valley Cottage, N.Y.
Dava International Inc., Fort Lee, N.J.
Glenmark Generics Inc. USA, Mahwah, N.J.

How FDA flushes the toilet:
Companies receiving the warning letters have 15 days to give the FDA a plan to discontinue marketing the unapproved drugs. Manufacturers have 90 days to cease manufacturing of 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.

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