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FDA Warns Firms Selling Unapproved Drugs

9 Prescription Narcotics Makers Are New Target of FDA Push
WebMD Health News
Reviewed by Louise Chang, MD

March 31, 2009 -- Nine drug companies selling 14 prescription narcotics are the latest target of the FDA's effort to bring thousands of unapproved drugs under FDA scrutiny.

The drugs aren't known to be unsafe. But because the drugs are sold without FDA approval, the agency has no way of knowing whether they are made safely, contain labeled ingredients, or carry correct dosages, says Deborah Autor, JD, director of the office of compliance at FDA's Center for Drug Evaluation and Research.

"Companies owe it to patients to ensure their drugs are legally marketed," Autor said at a news conference. "Today's action is about ensuring Americans have safe and effective drugs and getting the message to companies that they have a responsibility to patients."

The FDA is giving the firms 15 days to respond to its warning. The firms have 60 days to stop making the unapproved drugs and 90 days to stop distributing them. What happens after that?

"They will be subject to immediate enforcement actions," Autor said. "One company's violation of our deadline resulted in seizure of $24 million of their unapproved drugs."

Firms may claim that their drugs are "legacy" or "grandfathered" drugs that were on the market before FDA regulations took effect. But Autor said the FDA believes there is no such thing as a legacy drug and that very few drugs actually fall under the grandfather clause.

The 14 drugs targeted today are high concentrate morphine sulfate oral solutions and immediate-release tablets containing morphine sulfate, hydromorphone, or oxycodone. No oxycodone capsules are involved in the action.

The firms and drugs subject to today's FDA warning letters are:



Mallinckrodt Inc. Pharmaceuticals Group

Morphine Sulfate Concentrate Oral Solution 20 mg/mL

Boehringer Ingelheim Roxane Inc.

Roxanol Oral Solution, 20 mg/mL;
Roxicodone Tablets, 5 mg

Roxane Laboratories Inc.

Hydromorphone Hydrochloride Tablets, 2 mg and 4 mg

Glenmark Generics Inc.

Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/mL;
Morphine Sulfate Solution Immediate Release Oral Solution, 20 mg/5 mL

Lannett Company Inc.

Morphine Sulfate Solution Immediate Release 20 mg/mL;
Hydromorphone HCl Tablets, 2 mg and 4 mg

Lehigh Valley Technologies Inc.

Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Concentrate, 20 mg/mL

Physicians Total Care Inc.

Morphine Sulfate Immediate Release Tablets, 30 mg;
Hydromorphone Tablets, 2 mg;
Hydromorphone Hydrochloride Tablets 4 mg

Xanodyne Pharmaceuticals Inc.

Roxanol Oral Solution, 20 mg/mL;
Roxicodone Tablets, 5 mg

Cody Laboratories Inc.

Morphine Sulfate Solution Immediate Release 20 mg/mL


Autor said that while some patients are taking the unapproved narcotics, there are plenty of approved brands of the same medications. She promised there will be no shortage of these important pain medications.

Many consumers take the unapproved drugs named in today's action. One of the tablets, Autor said, has more than half of the market for that particular medication.

Drug companies shouldn't be surprised. The FDA began its unapproved-drug crackdown in June 2006. Since then, Autor said, 200 firms and 900 drug products have been subject to FDA actions.

"There is no specific information on safety concerns," Autor said. "But lack of assurance of purity and quality raises questions. These manufacturers have not submitted data to FDA that guarantee the safety and purity of their products."

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