Glucovance, combination therapy for type 2 diabetes, is approved

Drug Store News, August 28, 2000

The FDA has approved Bristol-Myers Squibb's Glucovance (glyburide and metformin HC1 tablets) for use along with diet and exercise, as an initial drug therapy for type 2 diabetics.

The drug was also approved as second-line therapy for patients with type 2 diabetes who are currently taking a sulfonylurea, in conjunction with a regimen of diet and exercise, but whose blood sugar levels are inadequately controlled. Glucovance combines glyburide and Glucophage, the two most widely prescribed oral antidiabetic agents, in a single pill.

Glucovance will be available in three dosing strengths, including 1.25 mg/250 mg (glyburide metformin) tablets, 2.5 mg/500 mg tablets and 5 mg/500 mg.

Glucophage (metformin), which had more than $1.3 billion in sales in 1999, loses patent protection in September. Bristol-Myers will have market exclusivity for Glucovance for three years.