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The US Food and Drug Administration (FDA) has requested more information from two leading drug companies about their new Certriad cholesterol drug before allowing it to go on sale.
AstraZeneca and Abbott Laboratories said the new drug combines cholesterol pills TriLipix and Crestor.
They were asked for more detail in a so-called complete response letter (CRL) after submitting an application.
The statin drug Crestor is produced by AstraZeneca and lowers problematic cholesterol while increasing “good” cholesterol.
Abbott’s TriLipix is part of a class of drugs called fibrates that raise “good” HDL cholesterol while reducing triglycerides and “bad” LDL cholesterol.
Studies conducted by the companies compared the combination pill versus separate treatment with statin and fibrate drugs.
The companies’ application to the FDA seeks approval to treat dyslipidemia, a disorder characterized by elevated cholesterol and triglycerides, a type of fat found in the blood stream. More than 100 million adults in the U.S. have the disorder, according to the American Heart Association.
The companies said they will continue discussions with the FDA to “determine the next steps,” while responding to the request for more information.
Copyright Press Association 2010