April 1, 2009 / 12:50 AM / in 9 years

FDA warns firms selling unapproved narcotics

WASHINGTON (Reuters) - U.S. regulators warned nine companies on Tuesday to stop selling 14 unapproved narcotic pain medicines, part of an ongoing effort to rid the market of drugs without proper clearance.

Companies that received the warnings included Boehringer Ingelheim’s Roxane Inc unit, Covidien Ltd’s Mallinckrodt unit and Glenmark Pharmaceuticals.

The Food and Drug Administration said the widely used prescription medicines contained morphine, hydromorphone or oxycodone. Companies must stop manufacturing the unapproved versions within 60 days and stop shipments within 90 days.

The FDA said there were enough approved products with those pain-killing ingredients to meet patient needs and no shortage was expected.

Covidien will comply with the FDA’s order and consider whether to seek agency approval to sell its product, a generic morphine solution, company spokesman Steve Littlejohn said. The product is not material to Covidien with annual revenue well below $10 million, Littlejohn said.

The drug’s sales are not material to Covidien, he said.

Boehringer said it had applied for FDA approval for its 4-milligram strength of hydromorphone hydrochloride tablets. A 2-milligram version was discontinued in 2008, and an 8-milligram dose already is approved, the company said.

Officials at other companies could not be reached or had no immediate comment.

The FDA move was the latest step since 2006 to crack down on drugs that slip through the approval process. About 2 percent of prescriptions in the United States are filled with unapproved drugs, the FDA has estimated.

Reporting by Lisa Richwine; Editing by Bernard Orr

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