GSK Expects Paxil CR, Avandamet Shipments To Resume “Within Months”
This article was originally published in The Pink Sheet Daily
Executive Summary
The Cidra, Puerto Rico manufacturing facility that was the subject of an FDA seizure action has been placed under a consent decree, GSK announces. Based on the validation requirements outlined in decree, products can begin shipping mid-year, the company says.
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GSK Resumes Shipment Of Paxil CR, Plans 30-Day Free Trial Program To Relaunch
Paxil CR is back on pharmacy shelves after compliance concerns kept the antidepressant out of production for four months. The company expects to return Avandamet to the market within two weeks. FDA seized all lots of the products in March.