RPI gets USFDA nod for more dosages of Glimepiride

Ranbaxy Laboratories today said it had received tentative approval from the US Food and Drug Administration (US FDA) approval for more dosages of diabetes drug Glimepiride and expected to launch the product in the US market by October this year.

Ranbaxy Pharmaceutical (RPI), the wholly owned subsidiary of Ranbaxy Labs, said it had further received approval for three and six MG dosages, adding to one, two, four and eight MG approvals received earlier.

"Glimeperide tablets, one, two and four MG strengths are available through the innovator company. RPI will offer these tablets, as well as three, six and eight MG that are additional strengths developed through Ranbaxy's R&D. The product will be launched following final approval from the FDA on October 6," Jim Meehan vice-president, sales and marketing, of RPI said in a statement.

The drug, a generic version of Sanofi-Aventis' Amaryl, had sales of $336.6 million in the 12 months to March, according to IMS figures, Ranbaxy said.