GlaxoSmithKline plc told staff it would cease operations at the Finisklin plant by the end of 2013 as part of an overall review of its business.

Parker Waichman Alonso LLP announces that they have filed a lawsuit against GlaxoSmithKline plc and Procter & Gamble Co. on behalf of an Nebraska woman who was diagnosed with neuropathy attributed to the use of Super PoliGrip(R) and Fixodent(R) denture adhesive creams. According to complaint, Jennifer J. Cornett, 61, received dentures approximately 9 years ago, and has used Super PoliGrip(R) and Fixodent(R). Ms. Cornett stopped using the denture adhesive creams after she was diagnosed with neuropathy attributed to excess zinc and copper depletion attributable to Super PoliGrip(R) and Fixodent(R). Her lawsuit alleges that Ms. Cornett now suffers from profound and permanent neurological injuries, which have left her unable to perform her normal, customary, and daily activities. The lawsuit maintains that Super PoliGrip(R) and Fixodent(R) contain a form of zinc, which is bonded to an unknown formulation. A small amount of zinc is necessary for a balanced diet. However, being exposed to an excessive amount of zinc can result in copper depletion and serious negative adverse neurological effects. In August 2008, the peer reviewed journal 'Neurology' reported on four patients suffering from neuropathy and other neurological symptoms typical of zinc poisoning and copper depletion. It was determined that excess use of denture cream could have been responsible for their symptoms. The complaint further alleges that the defendants failed to warn about their products' risks and failed to provide adequate warnings about the zinc in Super PoliGrip(R) and Fixodent(R), or adequate instructions to prevent deviation from accepted use. According to the lawsuit, had the defendants properly disclosed the risks associated with Super PoliGrip(R) and Fixodent(R), Ms. Cornett would never have used the products. Ms. Cornett's lawsuit names GlaxoSmithKline, the maker of Super PoliGrip(R), and Procter and Gamble Manufacturing Corp., the maker of Fixodent(R), as well as their subsidiaries, as defendants. This lawsuit is the latest of many filed by Parker Waichman Alonso LLP on behalf of the victims of zinc-containing denture adhesive creams. Ms. Cornett's lawsuit, along with dozens of others filed before it, has been consolidated for centralized and coordinated pre-trial proceedings in the Denture Cream Products Liability Litigation in the United States District Court for the Southern District of Florida, Miami Division, before the Honorable Judge Cecilia Altonaga (MDL No. 2051). Andres F. Alonso Esq., a partner with Parker Waichman Alonso LLP, was appointed Co-Lead Counsel to the Plaintiffs' Steering Committee in the litigation by Judge Altonaga in an order filed on July 13, 2009. On October 22, 2009, Mr. Alonso attended the most recent case management conference in the Denture Cream Products Liability Litigation.

GlaxoSmithKline plc and Xenoport, Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. The NDA currently under review by the FDA is for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The original PDUFA date for this NDA review was November 9, 2009. The FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) was necessary for GSK1838262. In response to FDA's request, GSK submitted a proposed REMS. The FDA accepted this submission as a solicited major amendment to the GSK1838262 NDA. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment that provides a substantial amount of new data not previously reviewed by the FDA.