Ranbaxy Laboratories Ltd has received tentative approval from the US Food & Drug Administration to manufacture and market Glimepiride Tablets 1 mg, 2 mg, 4 mg and 8 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. 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 Glimepiride and insulin may increase the potential for hypoglycemia.

"This product represents an interesting opportunity for Ranbaxy in which we will offer four strengths of this oral hypoglycemic agent to support patient compliance. The product will be launched following final approval from the FDA on October 06, 2005," said Jim Meehan, Vice President of Sales & Marketing for Ranbaxy Pharmaceuticals Inc.

Total annual market sales for Glimepiride were $ 336.6 million (+22.4%) (IMS - MAT: March 2005).