GlaxoSmithKline this morning said that it has signed an agreement with the US Food and Drug Administration to allow an independent review of its Puerto Rico manufacturing facility and expects production of both its long-acting antidepressant Paxil CR (paroxetine controlled-release) and its antidiabetic agent Avandamet (rosiglitazone plus metformin) to recommence mid-year.
Back in February, GSK withdrew select batches of both Paxil CR and Avandamet after manufacturing deficiencies were observed in a small number of tablets. However, the FDA took a stronger stance and – the following month – halted supplies of both medicines in the USA [[07/03/05a]], [[09/03/05c]].
No financial penalty has been levied, although the agreement includes a $10 million a year fine should GSK fail to meet its terms, as well as a $650 million bond to ensure previously withheld product is destroyed. The news will likely be a relief to the UK giant, which says it expects to meet the terms of the bond within a 90-day period, as the quality control problems have had widespread consequences. Just this week, GSK and Health Canada warned patients to rigorously check their medication because of manufacturing issues affecting six of its drugs - Avandamet and Avandia (rosiglitazone), the heart medication Coreg (carvedilol), Paxil (paroxetine) and Paxil CR (paroxetine controlled release) for depression, the non-steroidal anti-inflammatory Relafen (nabumetone) and a paroxetine compound distributed by Ratiopharm. [[25/04/05d]].
Earnings expectations for 2005 remain within the low double-digit range.