New Delhi, July 21
RANBAXY Laboratories Ltd has received tentative approval from the US Food & Drug Administration (FDA) to manufacture and market Glimepiride tablets 1 mg, 2 mg, 4 mg and 8 mg to lower blood glucose.
The total annual market sales for Glimepiride were $336.6 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).
It 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 a notice to the Bombay Stock Exchange, Mr Jim Meehan, Vice-President of Sales & Marketing, Ranbaxy Pharmaceuticals Inc said, "We are pleased to receive this tentative approval for Glimepiride tablets. This product represents an interesting opportunity for Ranbaxy. It will be launched following final approval from the FDA on October 6, 2005."