US FDA Approves Aurobindo ANDA for Generic Metformin

Medium-sized Indian drugmaker Aurobindo Pharma has announced that the US FDA has approved its abbreviated new drug application (ANDA) for a generic version of Metformin, a diabetes therapy marketed by German drug major Merck KGaA.

In January, the generics maker claimed that its four Indian manufacturing plants would be ready to begin exports of the drug upon a final approval.

Merck KGaA's sales of Metformin, an antihyperglycaemic and key ingredient in the company's Glucophage diabetes line, have already declined by 15% in 2004 to EUR274mn (US$361.81mn) as a result of generic competition. Meanwhile, at the end of last year Aurobindo reported that it had 64 drug master files and 15 ANDAs or European equivalents filed with regulatory authorities.