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FDA approves new Avandamet dosage strengths for the treatment of type 2 diabetes
Philadelphia | Thursday, August 28, 2003, 08:00 Hrs  [IST]

GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) approved new dosage strengths for Avandamet -- a treatment that combines two important diabetes medications in a convenient pill. The new Avandamet dosages of 1 gram metformin combined with 2 mg or 4 mg rosiglitazone will be available to patients in approximately six weeks.

"GlaxoSmithKline is pleased with the FDA's approval of the new Avandamet 1 gram tablets as they will offer additional dosing flexibility for the many type 2 diabetes patients who are currently taking a total daily dose of 2 grams of metformin," said David Brand, Vice President, Metabolic/Endocrine Marketing, GlaxoSmithKline. "Over the long-term, many patients on traditional agents do not reach the American Diabetes Association (ADA) recommended goal for blood sugar control, which puts them at increased risk for diabetes-related complications such as heart disease. With Avandamet, we look to provide an effective and convenient treatment option for patients to help manage their type 2 diabetes."

Avandamet was approved by the FDA in October 2002 as an adjunct to diet and exercise to improve blood sugar control in people with type 2 diabetes who are already treated with Avandia (rosiglitazone maleate) and metformin as separate tablets, or who are not adequately controlled on metformin alone. In addition to the new dosages, which will be available to patients in approximately six weeks, Avandamet is currently available in three tablet strengths of rosiglitazone/metformin, respectively: 1 mg /500 mg, 2 mg/500 mg, 4 mg/500 mg.

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