Another setback for Ranbaxy as US FDA says 'no' to its generic Flomax

Following tentative US Food and Drug Administration approval to launch a generic version of Boehringer Ingelheim and Astellas' urinary disorder drug Flomax (tamsulosin) in the USA as far back as 2007, yesterday Indian drug major Ranbaxy suffered a severe disappointment when the agency declined to give final clearance for the application, seeing the firm's shares fall more than 6%, but trimming the losses to 1.3% by 1:18 pm yesterday at 473 rupees, while the main Mumbai market was up 0.9%.

Flomax, which is used to treat enlarged prostate glands, is marketed in the US by Boehringer Ingelheim, had annual sales of about $2.1 billion in 2009. Ranbaxy, India''s biggest drugmaker by sales and which is majority-owned by Japan's Daiichi Sankyo, had expected to debut Flomax in the USA on March 2, eight weeks before the drug's patent expires in the USA following an out-of-court settlement in 2007.

'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,' Ranbaxy said in a statement on Wednesday. However, it did not give any reasons for not getting the approval adding that the company, through the settlement, did however enable the entry of an alternate generic that would benefit consumers.