Europe unaffected by GSK’s manufacturing problems

pharmafile | March 31, 2005 | News story | Sales and Marketing |   

Batches of GlaxoSmithKline's diabetes treatment Avandamet and depression treatment Paxil CR have been seized in the US due to continuing concerns about manufacturing problems at the company's Puerto Rico plant.

The EMEA said it agreed with an FDA assessment that no recall of products was required in the foreseeable future, but the European regulator said its inspectors will visit the Puerto Rico plant shortly and will be ready for any implications for EU patients.

GSK maintained that the seized medicines do not pose a risk to patients but said it was working with the FDA to meet its requirements.

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