Princeton, NJ - The FDA has approved Bristol-Myers Squibb ' s new type 2 diabetes treatment Glucovance?, which combines the oral antidiabetic agents glyburide and metformin into one pill, the company announced.
Glucovane is indicated as initial drug therapy for type 2 diabetes, along with diet and exercise, and as second-line therapy in patients whose glucose levels cannot be adequately controlled with diet, exercise, and metformin or a sulfonylurea.
The drug will be available in three dosing strengths, 1.25 mg glyburide/250 mg metformin, 2.5 mg/500 mg, and 5 mg/500 mg tablets.
The company warned that patients taking heart failure medications, drink excessive alcohol and those with kidney and liver problems should not take Glucovance.
Bristol-Myers Squibb has been under recent scrutiny for withdrawing a New Drug Application for its heavily promoted hypertension and heart failure drug omapatrilat in April after the FDA expressed concerns about the drug's side effects, as reported by heart wire .
Heartwire from Medscape © 2000
Cite this: FDA approves new diabetes drug - Medscape - Aug 02, 2000.