Glaxo Resumes U.S. Paxil CR Sales

GlaxoSmithKline (GSK) said Monday said it has resumed selling the antidepressant Paxil CR in the U.S., adding that the drug will become available in other markets soon.

Batches of the drug were seized in March by federal marshals after the Food and Drug Administration said the company had failed to improve its manufacturing practices at a plant in Puerto Rico. The FDA also seized the diabetes drug Avandamet, citing problems at the Puerto Rico plant. Neither the FDA nor the company reported any injuries to patients.

GlaxoSmithKline said Monday that it would resupply Avandamet to wholesalers within two weeks.

The company, which signed a consent agreement with the FDA on April 28 to fix the problems, said it "has identified the source of the manufacturing issues and has implemented revisions to those processes."

The FDA said it ordered the rare product seizure because GlaxoSmithKline hadn't acted quickly to fix problems that had been identified during inspections of the plant in 2003 and 2004.

When GlaxoSmithKline announced the consent agreement, it said the pact wouldn't have any effect on the predicted earnings per share growth for 2005 in the "low double-digit range" in terms of constant exchange rates.

GlaxoSmithKline's stock was down 49 cents, or 1%, to $48.76 in late morning trading Monday.

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