US FDA rejects Ranbaxy's application for generic Flomax

The US Food and Drug Administration (FDA) yesterday rejected an application by Ranbaxy Laboratories Limited, among the top 10 generic manufacturers in the world, to market in the US its generic version of Flomax, used in the treatment of enlarged prostate glands.

Ranbaxy, now part of Japan's Daiichi Sankyo group, said in a statement today, ''We regret that despite our best efforts we were not able to get an approval for the subject product, and hence will not be in a position to launch the product.''

''However Ranbaxy, through its settlement, did enable the entry of an alternate generic, that would benefit the consumers,'' it added.

Ranbaxy had expected to launch a cheaper generic version of Astellas Pharma's Flomax in the US yesterday, which would have given it eight weeks of exclusive sales, but was facing competition from Impax Laboratories Inc, which was also waiting for FDA approval of its versions of Flomax.

The FDA said in a statement yesterday that it has approved the first generic version of the drug known as Tamsulosin from Impax Labs Inc, which launched the drug in the US market yesterday.

In 2007, the FDA had granted tentative approval to Ranbaxy to launch the generic version of Flomax, but today's rejection is a warning to Indian drug makers for violating good manufacturing practice.

Neither Ranbaxy nor the FDA gave any reasons for the rejection.