RANBAXY LOSES OUT ON FDA DELAY, FAILS TO LAUNCH CLONE OF BLOCKBUSTER DRUG

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RANBAXY Laboratories’ stab at potential sales of millions of dollars has come to naught after it failed to secure the American drug regulator’s permission to market the generic, or copycat, version of a blockbuster drug in the US, the latest in a growing list of setbacks for the Indian pharma company.

   Ranbaxy, the Indian unit of Japanese drugmaker Daiichi Sankyo, was to launch the generic version of Japan-based Astellas’ Flomax on March 2 in the US, eight weeks before the drug’s patent expires in that country following an out-ofcourt settlement in 2007.

   Flomax, used to treat prostrate enlargement and marketed by German drugmaker Boehringer Ingelheim, recorded sales of around $2 billion in the US last year.

   The US Food & Drug Administration’s (FDA) refusal to give permission is another blow for the Gurgaon-based drugmaker, whose 30 drugs were banned by the FDA in September 2008. The FDA also halted fresh approval for two of its Indian plants for violating US manufacturing rules. Early last year, the FDA also delayed the launch of its generic version of GlaxoSmithKline’s Imitrex.

   “We regret that despite our best efforts we were not able to get an approval for the subject product (Flomax), and hence will not be in a position to launch the product,“ said the Ranbaxy spokesman in India, adding that the company, through the settlement, did however enable the entry of an alternate generic that would benefit consumers.

   The spokesman did not set a new launch date. Even if Ranbaxy is able to launch the product, its upside will be severely limited as it enjoyed only an eight-week marketing exclusivity window.

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