Indian drug manufacturer, Ranbaxy Pharmaceuticals has tentative approval from the U.S. Food and Drug Administration to manufacture and market Glimepiride Tablets, 3 mg and 6 mg.
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. Glimepiride 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.
"We are pleased to receive this tentative approval for Glimepiride Tablets. This product represents an interesting opportunity for Ranbaxy in which we will offer six strengths of this oral hypoglycemic agent to support dosing flexibility that will be of benefit to both prescribers and patients. Glimepiride Tablets, 1, 2 and 4 mg strengths are available through the innovator company. RPI will offer these tablet strengths, as well as 3, 6, and 8 mg that are additional strengths developed through Ranbaxy's R&D organization. Product will be launched following final approval from the FDA on October 6, 2005," according to Jim Meehan, Vice President of Sales and Marketing for RPI.