Issue 145 Item 13 FDA Approves Use of Rosiglitazone With Insulin

Both Avandia and Actos indicated for use with insulin. GlaxoSmithKline has received a supplemental approval from the US Food and Drug Administration (FDA) that will allow it to market its diabetes drug rosiglitazone maleate (Avandia) for use in combination with insulin.

Avandia currently is indicated for use by itself or with metformin (Glucophage) for type 2 diabetes patients who are not able to control their disease with diet and exercise alone. In a notice issued on Friday, the FDA said it approved the new indication for treatment with Avandia, which comes in 2-mg, 4-mg and 8-mg tablets.

The FDA approval gives Avandia a similar label to the drug’s closest competitor, Eli Lilly’s pioglitazone (Actos), which is indicated for use by itself or in combination with insulin.

Glaxo recently also earned FDA approval for Avandamet, a single tablet combination of Avandia and metformin.