Ranbaxy gets US FDA approval on Atenolol tablets

Published: 3-Jan-2007
Regulatory Research & Development


Ranbaxy Laboratories, headquartered in India, 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 FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Tenormin of Astra-Zeneca LP.

Atenolol is indicated in the management of hypertension and total annual market sales were estimated at US$133.6m (IMS - MAT: September 2006). The drugs will be sold through Ranbaxy Pharmaceuticals Inc, based in Jacksonville, Florida, a wholly owned subsidiary of Ranbaxy Laboratories.

The approval is the result of a strategic alliance with Ipca Laboratories of Mumbai, India, which plans to develop a number of generic prescription pharmaceutical products to be marketed by RPI in the US in the future.

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