LONDON and PHILADELPHIA, April 28 /PRNewswire-FirstCall/ — GlaxoSmithKline announced that it has reached agreement on a Consent Decree with the FDA regarding the Company’s Cidra, Puerto Rico, manufacturing site.
The Consent Decree provides for an independent expert to review manufacturing processes at the site for compliance with FDA Good Manufacturing Practice (GMP) requirements. There is further provision for the Company to provide a report to the FDA on any deficiencies identified in this review, setting out a corrective plan and timetable for completion. The Company is fully committed to working cooperatively with the FDA to address any such issues in a timely fashion.
With respect to Paxil CR (paroxetine hydrochloride controlled release) tablets and Avandamet (rosiglitazone maleate / metformin hydrochloride) tablets, distribution of which was halted in March of this year, GSK believes it has identified the source of the manufacturing issues related to both of these products, and has already implemented revisions to those manufacturing processes. The company is now validating those solutions through a third party.
Based on the terms of the Consent Decree, the Company can continue to manufacture products at the site, and expects to begin re-supplying the US and other markets with both Paxil CR and Avandamet in mid-year.
No financial penalties have been imposed under the Consent Decree. This Consent Decree allows for potential future penalties up to a maximum of $10 million a year if the Company fails to meet the terms of the agreement. The Company is also required to post a $650 million bond to ensure that product previously withheld by the FDA is appropriately destroyed or reconditioned. The Company anticipates meeting all requirements of the bond within 90 days following entry of the Decree, after which the bond will be cancelled.
In light of the resolution reached with the FDA, the Company confirms that earnings guidance for 2005 is EPS percentage growth (at constant exchange rates) in the low double-digit range on an IFRS basis.