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www.fdanews.com/articles/88268-glaxosmithkline-receives-fda-approval-for-avandamet

GLAXOSMITHKLINE RECEIVES FDA APPROVAL FOR AVANDAMET

July 11, 2006

GlaxoSmithKline has received FDA approval for Avandamet (rosiglitazone maleate and metformin HCl) for use as initial treatment of Type 2 diabetes as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy -- it was indicated for use in patients who were uncontrolled on metformin monotherapy. Now, with this recent approval, physicians can start their Type 2 diabetes patients on Avandamet.

Avandamet is the only combination of a thiazolidinedione, rosiglitazone maleate (separately marketed as Avandia) and metformin HCl with approved use as initial therapy of Type 2 diabetes. The drug is indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate.