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US FDA stops distribution of GSK's for Paxil CR & Avandamet
London | Saturday, March 5, 2005, 08:00 Hrs  [IST]

The US Food and Drug Administration has halted distribution of supplies of two of GlaxoSmithKline's medicines- Avandamet (rosiglitazone maleate / metformin hydrochloride) tablets, used to treat type 2 diabetes, and Paxil CR (paroxetine hydrochloride controlled release) tablets, a treatment for depression and several anxiety disorders-due to manufacturing issues:

The FDA action relates to all strengths of Paxil CR (12.5 mg, 25 mg, and 37.5 mg) as well as Avandamet (1 mg, 2 mg, and 4 mg).

GSK believes that the manufacturing issues do not pose a health risk to patients. GSK agrees with the FDA that patients who use these two medicines should continue taking their tablets and talk with their healthcare provider if they have questions. The company is working with the FDA to resolve these issues as quickly as possible, a GSK release said here.

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