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Ranbaxy looks to market additional doses of diabetes drug

Ranbaxy Pharmaceuticals has received tentative approval from the FDA to manufacture and market additional strengths of its diabetes drug glimepiride.

Ranbaxy plans to launch the alternative dosages in October this year, upon final regulatory approval. Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type II diabetes whose hyperglycemia cannot be controlled by diet and exercise alone.

The Ranbaxy formulation is a generic version of Sanofi-Aventis’ Amaryl tablets. Ranbaxy estimates the total annual market sales for Amaryl to be $336.6 million up until March 2005.

“Glimepiride tablets, 1, 2 and 4mg strengths are available through the innovator company. RPI (Ranbaxy) will offer these tablet strengths, as well as 3, 6, and 8mg that are additional strengths developed through Ranbaxy’s R&D organization,” said Jim Meehan, vice president of sales and marketing for Ranbaxy.

Ranbaxy Laboratories recently reported a 47% drop in second quarter net profits, which the company attributed to increased R&D expenses incurred through its expansion of bio-studies for generics and intense pricing pressure in the US market.