Glenmark stops marketing codeine sulfate pills in US

India’s generic firm Glenmark has stopped selling codeine sulfate pills used to manage pain, following US FDA’s directive to stop marketing the tablets that have not received FDA approval.

Glenmark’s stoppage of selling codeine sulfate pills came after the Food and Drug Administration asked the company to end the sale of the drug which earlier didn’t require the health regulator’s approval.

US FDA has issued warning letters to four companies that they must stop marketing unapproved codeine sulfate tablets. Codeine sulfatedrugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain.

US FDA had warned Glenmark Generics on the sale of morphine sulphate in March, which was also categorized as an unapproved product.

Glenmark Generics had complied with the FDA’s directive on morphine sulphate However, the regulator had subsequently exercised its “enforcement discretion” and permitted the company to continue to distribute a version of the drug for up to 180 days through a letter dated April 9, reports said.

Revenue impact from the US FDA action is only marginal, Glenmark stated.

Apart from Glenmark Generics Inc. USA, Mahwah, N.J., Lehigh Valley Technologies Inc. Allentown, Penn., Cerovene Inc., Valley Cottage N.Y, and Dava International Inc., Fort Lee, N.J. are the other firms received warning letters from US FDA.

All the four companies are marketing codeine sulfate tablets in 30 mg and 60 mg strengths.

FDA has no evidence the narcotic analgesic tablets used to treat pain are safe or effective, the regulatory officials said.

Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug, US FDA officials said.

US FDA did not anticipate a supply problem for codeine sulfate tablets because of the warning letters and subsequent withdrawal of the drugs.

“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).

Drug companies should ensure all drugs they make and market have appropriate FDA approval, US FDA said.

Glenmark, Lehig Valley Tech, Cerovene and Dava International 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.

US FDA’s initiative against the marketing of unapproved codeine sulfate drugs is part of its programme 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.

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, US FDA announcement said.