GSK 's Avandamet gets FDA approval for type 2 diabetes

UK drug major GlaxoSmithKline says that the US Food and Drug Administration has approved Avandamet (rosiglitazone maleate and metformin HCL) for the initial treatment of type 2 diabetes as an adjunct to diet and exercise. Previously, the drug was approved as a second-line therapy for patients who could not achieve control using metformin monotherapy. The company added that it now has adequate supplies of the product following the FDA's 2005 confiscation of its stocks as a result of the company's failure to address concerns relating to a manufacturing plant in Puerto Rico. GSK added that, despite its agreement with the agency entered into one month after the seizure of the product, it has taken the company until now to manufacture supplies of the drug to sufficient levels to warrant resumption of its marketing activities.