Unapproved liquid morphine can still be sold in U.S.: FDA

WASHINGTON Thu Apr 9, 2009 7:14pm EDT

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WASHINGTON (Reuters) - Companies marketing a liquid morphine that was unapproved for sale in the United States can keep selling it for now because regulators have determined it is essential for relieving pain in some patients who are near death.

The Food and Drug Administration (FDA), which recently told the companies to stop marketing the product here, said it was reversing course after discussions with groups that provide end-of-life care. Advocates said the morphine elixir, sold in a potent 20-milligram per milliliter strength, was the only pain relief option for some dying patients.

On March 30, the FDA sent letters to nine companies telling them to stop selling 14 unapproved narcotic pain medicines as part of an effort to rid the market of drugs that do not have proper clearance. The companies were given 60 days to stop making them.

Seven of those companies make or distribute the liquid morphine that is used for some dying patients.

On Thursday, the FDA sent new letters to the makers or distributors of the liquid morphine telling them sales could continue for now, according to Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research.

Sales of unapproved versions will have to stop after an acceptable liquid morphine wins approval or when the FDA determines that appropriate alternatives are available, Throckmorton told reporters.

Makers of the morphine solution include Glenmark Generics, a unit of Glenmark Pharmaceuticals; Lannett Company, and Covidien Ltd unit Mallinckrodt, according to information on the FDA's website.

(Reporting by Lisa Richwine; Editing by Toni Reinhold)

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