The US drug regulator has opposed American firm Mylan’s request to strip Ranbaxy Laboratories of its six months exclusive right to sell a low-priced version of the world’s best-selling drug Lipitor in the US. The US Food and Drug Authority (FDA) has in principle allowed Ranbaxy to sell a generic version of the medicine from end of 2011, after original drugmaker Pfizer’s patent expires in November. 

The six months headway can bring in as much as $500-600 million in revenues for India’s largest drugmaker. Last month, Mylan moved a local US court saying that FDA’s approval to Ranbaxy should be quashed as the Indian firm isn’t eligible for the marketing exclusivity since it submitted false and unreliable data from its Poanta Sahib plant. 

The FDA in its reply said it is for the regulator to determine if Ranbaxy’s application should be approved or not. Ranbaxy, now owned by Japan's Daiichi Sankyo, is yet to get final approval from the FDA for the drug even as it continues to work on a comprehensive settlement with the regulator.crackcrack

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