RANBAXY'S GENERIC TENORMIN GRANTED FINAL APPROVAL

Ranbaxy Laboratories announced it has received final approval from the FDA to manufacture and market atenolol tablets, 25, 50 and 100 mg. The Office of Generic Drugs determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug, AstraZeneca's Tenormin. Total market sales for atenolol were $133.6 million for the year ending in September.

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 for the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality.

"This approval is the result of a strategic alliance with Ipca Laboratories of Mumbai, India, who will develop a number of generic prescription pharmaceutical products which will be marketed by [Ranbaxy] in the U.S. in the future following FDA approval," Jim Meehan, vice president of sales and marketing at Ranbaxy. "Atenolol tablets will be made available to our customers in the U.S. healthcare system during first quarter 2007."