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news.Ranbaxy Laboratories has received approval from the FDA to manufacture and market atenolol tablets, a generic version of AstraZeneca's beta blocker drug Tenormin.
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The FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as Tenormin.
Atenolol is indicated in the management of hypertension, which may be used alone or with other antihypertensive agents. Atenolol is also indicated for heart attack, arrhythmias and angina.
Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals Inc (RPI), said: “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.”
The company added that the approval was the result of a strategic alliance with Ipca Laboratories of Mumbai, India, which will develop a number of generic prescription pharmaceutical products for RPI in the US following US FDA approval.
RPI-labeled atenolol tablets will be available in the US healthcare system during the first quarter of 2007, according to Ranbaxy.