Ranbaxy Laboratories has received approval from the US Food and Drug Administration to manufacture and market Glimepiride Tablets, 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg.
According to a company release, the Office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Amaryl Tablets, a registered trademark of Aventis Pharmaceuticals, Inc. Total annual market sales for Amaryl Tablets were $349.5 million (+20.6%) (IMS - MAT: June 2005).
Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. The product may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone do not result in adequate glycemic control.
Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. Combined use of Glimepiride and insulin may increase the potential for hypoglycemia.