NEW DELHI: Ranbaxy Laboratories Limited (RLL) 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 Amaryl 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," Ranbaxy Pharmaceuticals Inc Vice-President Sales and Marketing Jim Meehan 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.
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