Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to manufacture and market Atenolol tablets USP 25 mg, 50 mg, and 100 mg.
The office of Generic Drugs, US Food and Drug Administration, has determined the company's formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Tenormin of AstraZeneca LP. Total annual market sales for Atenolol were $133.6 million
Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic. Atenolol is also indicated for the long-term management of patients with angina pectoris due to coronary atherosclerosis and is also indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce, cardiovascular mortality.
"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. This approval is the result of a strategic alliance with Ipca Laboratories Ltd of Mumbai, India, who will develop a number of generic prescription pharmaceutical products, which will be marketed by RPI in the US in the future following US FDA approval.
RPI labeled Atenolol tablets will be made available to our customers in the U S healthcare system during first quarter 2007." according to Jim Mechan, vice president of sales and marketing for the RPI, USA.