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FDA nod for Ranbaxy drug

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NEW DELHI: Ranbanxy Laboratories Ltd has received an approval from the US Food and Drug Administration to manufacture and market glimepiride tablets used for diabetes.

The Ranbaxy formulations have the same therapeutic effect as that of Aventis Pharmaceuticals's Amaryl tablets, which has total annual market sales of $349.5 million. Glimepiride is indicated as an adjunct 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.

In a statement, Mr Venkat Krishnan, Vice-President, Ranbaxy Inc of the US, said, "We are pleased to receive this final approval for glimepiride tablets.

"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."

Glimepiride will be launched immediately, and the company will now make a concerted effort to reach key buyers as quickly as possible, said Ranbaxy.

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