GlaxoSmithKline has resumed selling its antidepressant Paxil CR (paroxetine controlled-release) in the USA almost four months after the US Food and Drug Administration and the Department of Justice seized batches of the treatment for failing to meet manufacturing standards [[07/03/05a]].
The problems were at GSK’s Knoxville, Tennessee and Cidra, Puerto Rico facilities and there were fears that the firm could be hit with a hefty fine. However agreement with the FDA was reached, including a $650 million bond to ensure previously withheld product was destroyed, and an independent review of the facilities was carried out [[28/04/05c]].
GSK says that acting on the review’s recommendations, it has “identified the source of the manufacturing issues and has implemented revisions to those processes,” but reiterated that both the company and the FDA agreed at the time that the production problems posed no significant safety issues for patients.
Paxil CR will be back on markets outside the USA shortly and GSK added that another drug that was seized, the antidiabetic Avandamet (rosiglitazone plus metformin), will return to distribution within two weeks.
The news is also expected to boost the shareprice of SkyePharma which has a single-digit royalty deal with GSK for Paxil CR formulation which brings in much-needed revenue.
