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FDA Expects Consent Decree For GSK As Follow-Up To Seizure Action

Executive Summary

FDA expects to enter into a consent decree with GlaxoSmithKline to resolve manufacturing violations at its Cidra, Puerto Rico facility following the seizure of Paxil CR and Avandamet

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Paxil CR returns

GlaxoSmithKline resumes shipment of Paxil CR, four months after manufacturing problems led to FDA's seizure of the product at distribution and production facilities (1"The Pink Sheet" March 21, 2005, p. 15). Sales reps will offer 30-day free trial vouchers to support reintroduction; Paxil CR will be a "priority" for sales force, GSK says. Resupply of Avandamet, which also was seized by FDA, is projected to begin by mid-July...

Paxil CR returns

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