FDA orders nine drugmakers to stop selling unapproved narcotics

ROCKVILLE, Md. Nine companies received a warning from the Food and Drug Administration Monday to stop manufacturing unapproved narcotic drugs marketed as pain treatments.

The drugs affected, often called “grandfathered” drugs, lack approval because they typically predate current FDA requirements.

The agency sent warning letters to the companies concerning 14 drugs that include high-concentrate morphine sulfate oral solutions and immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone. Should the companies continue manufacturing and distributing the drugs, the FDA may take punitive action, the warning letters read. The action does not include capsules with oxycodone.

Companies that received the letters include Boehringer Ingelheim Roxane, Cody Labs, Glenmark Pharmaceuticals, Lannett Co., Lehigh Valley Technologies, Mallinckrodt Inc. Pharmaceuticals Group, Physicians Total Care, Roxane Labs and Xanodyne Pharmaceuticals.

“Consumers have a right to expect that their drugs meet the FDA’s safety and effectiveness standards,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. 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.”

Boehringer Ingelheim, which received the letters with regard to its Roxanol (morphine sulfate) oral solution and Roxicodone (oxycodine) tablets, has made the drugs since 1983. It said that because Xanodyne owns the rights to the drugs, it will be responsible for seeking FDA approval. Roxane Labs received a letter for its hydromorphone hydrochloride tablets. Boehringer Ingelheim said that it and Roxane had been proactive on the issue of unapproved drugs and would continue to work with the FDA.

The FDA said the letters were part of an initiative started in 2006 on the marketing of unapproved drugs.