Aurobindo Pharma, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market alendronate sodium tablets 10mg, 35mg and 70mg. This is the company's 73rd abbreviated new drug application (ANDA) approval from the USFDA.
Alendronate sodium tablets are the generic equivalent of Merck and Co Inc's Fosamax tablets 10mg, 35mg and 70mg, which are indicated for the treatment of osteoporosis (bone disease). Annual sales of alendronate sodium tablets in the US were approximately $1,982 million (Rs 8,324.4 crore) for the year ended December 2007 according to Merck's financial disclosures.
Aurobindo is in the first line of generics and got the FDA nod on the very first day post the expiry of the relevant patent. The product will be launched immediately in the US market, Aurobindo stated in a press release on Tuesday.