Mylan Sues U.S. FDA to Block Ranbaxy’s Sale of Lipitor Copy

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Mylan Inc. sued the U.S. Food and Drug Administration, seeking to block India’s Ranbaxy Laboratories Ltd.’s exclusive rights to sell a generic version of Pfizer Inc.’s cholesterol pill Lipitor, the world’s best-selling medicine.

Mylan and other generic-drug makers should be allowed to to enter the market as soon as Lipitor’s patent expires in June because of manufacturing violations at two Ranbaxy factories in India, Mylan said in a complaint filed March 18 in federal court in Washington. Ranbaxy, 64 percent owned by Tokyo-based Daiichi Sankyo Co., fell the most in almost two years in Mumbai.