BY OUR PHARMA CORRESPONDENT
22 July, 2005: US Food & Drug Administration has given tentative approval for Ranbaxy Laboratories Ltd’s oral hypoglycemic agent glimepiride.
The approval enables the Indian pharma major to make and market glimepiride tablets in strengths of 1 mg, 2 mg, 4 mg and 8 mg in the US market.
The product will be launched following final approval from the FDA on October 06, 2005, states an official release from Ranbaxy Pharmaceuticals Inc.
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 hyperglycaemia 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 glycaemic control.
Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent. Combined use glimepiride and insulin may increase the potential for hypoglycaemia.
Total annual market sales for glimepiride were $ 336.6 million (+22.4%) (IMS - MAT: March 2005), the release states.