Indian pharma major Ranbaxy Laboratories Limited has received the approval from the US Food and Drug Administration (FDA) to manufacture and market generic hypertension drug Atenolol in the country.
Ranbaxy plans to market Atenolol tablets of 25 mg, 50 mg, and 100 mg dosage manufactured by Mumbai-based Ipca Laboratories in the US from the first quarter of 2007, the company said in a statement Tuesday.
Ipca Laboratories has an arrangement with Ranbaxy's wholly owned Florida-based subsidiary Ranbaxy Pharmaceuticals Inc (RPI) for marketing its products in the US.
"The Office of Generic Drugs of the US Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Tenormin of AstraZeneca LP," Ranbaxy said.
Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other anti-hypertensive agents, particularly with a thiazide-type diuretic.
"We are pleased to receive this final FDA approval to market Atenolol tablets. This will further expand our product portfolio of affordable generic alternatives to the brand in the treatment of cardiovascular disorders," said Jim Meehan, vice president (sales and marketing) for Ranbaxy Pharmaceuticals Inc.
"This approval is the result of a strategic alliance with Ipca Laboratories that will develop a number of generic prescription pharmaceutical products which will be marketed by RPI in the US," he added.