Aurobindo Pharma Ltd has received the final approval from the US Food & Drug Administration (US FDA) to manufacture and market alendronate sodium tablets USP 10mg, 35mg and 70mg.
According to the company, it is a Paragraph IV certification. Alendronate sodium tablets are the generic equivalent of Merck & Co Inc's Fosamax tablets USP 10mg, 35mg and 70mg, which are indicated for the treatment of osteoporosis (bone disease). Annual sales of alendronate sodium tablets USP 10mg, 35mg and 70mg in the US were approximately US$ 1,982 million for the twelve months ending December 2007 according to Merck's financial disclosures.
Aurobindo is in the first line of generics and got the US FDA 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 company, within 8 months of the date of filing. It is Aurobindo's 73rd ANDA approval from the US FDA.