GSK's Paxil returns to US market

UK drug giant GlaxoSmithKline says it has returned its antidepressant Paxil CR (paroxetine HCl controlled-release) tablets to pharmacies across the USA, with other markets to follow shortly, following suspension of its sale due to manufacturing issues earlier this year (Marketletters passim).

In March, the US Food and Drug Administration seized both Paxil and the diabetes drug Avandamet (rosiglitazone maleate/metformin HCl) from distribution and manufacturing facilities. The agency found that Paxil CR tablets could be split apart, potentially leading to the absence of the active ingredient or controlled-release factor, while some Avandamet tables had the incorrect dose of one active ingredient.

GSK says it has now implemented revisions to the source of the production problem the nature of which, it says, did not relate to any significant safety issues. Consequently, the firm expects that distribution channels will also be resupplied with Avandament shortly.