Ranbaxy gets US nod for Glimepiride

Ranbaxy Laboratories Ltd on Friday said it has received approval from the US Food and Drug Administration to manufacture and market multiple dosages of anti-diabetes drug Glimepiride tablets.

In a statement, the company said it had received USFDA approval to manufacture and market Glimepiride Tablets in 1mg, 2mg, 3mg, 4mg, 6mg and 8mg.

The office of generic drugs, USFDA has determined the company's formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Amary Tablets, a registered trademark of Aventis Pharmaceuticals, Inc, whose annual market sales were estimated to be $349.5 million, it said.

"Glimepiride will be launched immediately, and we will now make a concerted effort to reach key buyers as quickly as possible," Jim Meehan, vice-president, sales and marketing Ranbaxy Pharmaceuticals Inc said.

The drug is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with non insulin-dependent (Type II) diabetes mellitus whose hyperglycemia cannot be controlled by diet and exercise alone.

"This product represents an interesting opportunity for Ranbaxy, in which we will offer a number of strengths of this oral hypoglycemic agent to support dosing flexibility that will benefit both prescribers and patients," Venkat Krishnan, vice president, Ranbaxy Inc USA, said.

Glimepiride Tablets of 1mg, 2mg and 4mg are available through the innovator company. RPI will offer these tablet strengths as well as tablets of 3mg, 6mg and 8mg that are additional strengths developed through Ranbaxy's R&D organization, Krishnan added.