On June 23, the FDA approved a fixed-dose combination of the meglitinide, repaglinide, with the biguanide, metformin HCl (PrandiMet; Novo Nordisk, Inc, and marketed by Sciele Pharma) for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus who are already being treated with a meglitinide and metformin or who have not achieved adequate glycemic control with either component alone. PrandiMet will be available by prescription during the second half of 2008. Use of the combination product is contraindicated in patients with renal impairment or metabolic acidosis and in those receiving both gemfibrozil and itraconazole. The FDA advises that renal function should be assessed and verified as normal before initiation of therapy and at least annually thereafter. Here’s the FDA label.
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