Ranbaxy gets tentative FDA nod for drug

Ranbaxy Laboratories Ltd today said it has received tentative approval from the US Food and Drug Administration to manufacture and market Glimepiride tablets of 1 mg, 2 mg, 4 mg and 8 mg.

"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 6, 2005," said Jim Meehan, vice president (sales and marketing), Ranbaxy Pharmaceuticals Inc.

Glimepiride is to be taken, in addition to diet and exercise, to lower the blood glucose in patients with non-insulin-dependent (Type-II) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone, a company release said.

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.