Ranbaxy Laboratories has received approval from the FDA to manufacture and market Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg. The Office of Generic Drugs, U.S. FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as AstraZeneca's drug Tenormin.
Atenolol is indicated in the management of hypertension. It may be used alone or with other antihypertensive agents. 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 acute myocardial infarction to reduce cardiovascular mortality.
"We are pleased to receive this final FDA approval to market Atenolol tablets," said Jim Meehan, vice president of sales and marketing for RPI. "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 U.S. in the future." Atenolol tablets will be made available to our customers in the U.S. during first quarter 2007, according to the company.