Mylan filed a lawsuit against the FDA seeking a court order to revoke Ranbaxy Laboratories' 180-day marketing exclusivity for generic Lipitor, a cholesterol-lowering drug from Pfizer. Mylan said Ranbaxy used "false and unreliable" manufacturing data in its FDA application. Mylan is also requesting that its version of Lipitor be allowed in the market after Pfizer's patent expires
The FDA rejected an application to market cholesterol drugs Lipitor and Zetia as a combination treatment because of a lack of manufacturing and stability data. Merck & Co., which developed Zetia with Schering-Plough, said it is reviewing the complete-response letter "to determine a new timetable for filing."
A study reported in the American Heart Journal indicates Merck's Vytorin, a combination of ezetimibe and simvastatin, is more effective than Lipitor in lowering LDL cholesterol. Vytorin lowers cholesterol by reducing cholesterol formation and by reducing cholesterol absorption from the intestine.
The effect of two cholesterol-lowering drugs on arterial plaque buildup were compared in a study sponsored by Pfizer, which makes Lipitor, one of the two drugs studied. The study found that Lipitor lowered the LDL cholesterol more than Pravachol, which is manufactured by Bristol-Myers Squibb.
Pfizer may be the first company to introduce a "superpill," one that combines its hypertension drug Norvasc and its cholesterol-lowering agent Lipitor. Merck will follow with a combination of Zocol and Zetia, while Bristol-Myers Squibb is developing a single-pill version of aspirin and Pravachol, its statin drug. These superpills could result in significant declines in heart disease, British researchers say.