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Paxil News

March 8th, 2005

"GlaxoSmithKline’s Paxil drug seizure leads to profit loss warnings"

Analysts are reassessing their earnings forecasts and are warning that at least $270 million of profits could be lost in the current financial year following the seizure of two major GlaxoSmithKline drugs by the FDA – diabetes treatment Avandamet and antidepressant Paxil CR.

The FDA said on March 4, 2005 that it was seizing batches of Avandamet and Paxil CR made at the factory due to quality problems. Some analysts believe the fact that U.S. marshals had to go in and seize supplies of the drugs suggested regulators had been pushed to wait on Glaxo to take adequate action.

Glaxo is expected to meet with the FDA within the upcoming weeks to resolve the manufacturing issues that led up to the Avandamet and Paxil withdrawal. A Glaxo spokesman said the company was doing everything it could to resolve manufacturing issues as quickly as possible, saying it was still too early to assess the financial impact of the Avandamet and Paxil seizures.

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