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Glaxo Resumes Paxil CR Sales After FDA Seizure

June 28, 2005|From Associated Press

GlaxoSmithKline has returned its antidepressant Paxil CR to the market, nearly four months after federal officials seized the drug from three factories for failing to meet manufacturing standards.

The pharmaceutical company said Paxil tablets were available in U.S. pharmacies, and other markets around the globe would soon stock them as well.

Glaxo said it had identified and fixed the source of the manufacturing problems at its Knoxville, Tenn., and Cidra, Puerto Rico, facilities. The improvements were certified by a third party, the company said.

Another drug that was seized, Avandamet, will return to distribution within two weeks, Glaxo said. Avandamet treats Type II diabetes; Paxil treats depression and panic disorder.

In March, Glaxo said Food and Drug Administration officials seized both drugs from the Tennessee distribution facility and manufacturing and distribution plant in Puerto Rico. Paxil CR and Avandamet are manufactured at the Puerto Rico facility.

The FDA found that Paxil CR tablets could be split apart, potentially leaving portions without the active ingredient or controlled-release characteristic. Some Avandamet tablets didn't have the correct dose of one active ingredient.

Although federal regulators did not believe that the drugs posed a significant threat to patients' health, they wanted to halt distribution until problems could be corrected.

The drugs were seized after an incomplete recall by Glaxo in February.

U.S. shares of London-based Glaxo, whose U.S. headquarters are in Philadelphia and North Carolina, fell by 40 cents to $48.85.

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