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Aurobindo drug gets US nod

Hyderabad, Aug. 5

Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market alendronate sodium tablets. They are the generic equivalent of Merck's Fosamax tablets which are indicated for the treatment of osteoporosis (bone disease). The annual sales of alendronate sodium tablets in the US were approximately $1,982 million in 2007, according to Merck's financial disclosures. Aurobindo is in the first line of generics and got the USFDA nod on the very first day post the expiry of the relevant patent and the product will be launched immediately in the US market. This has been one of fastest approvals received by the Hyderabad-based company (within eight months of the date of filing), according to a release. - Our Bureau

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