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Abbott/AstraZeneca's Certriad Bounced By FDA; ACCORD Is The Likely Culprit

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Abbott and AstraZeneca aren't providing any details about why the FDA issued a "complete response" letter for their cholesterol-lowering combo drug Certriad (rosuvastatin/fenofibric acid delayed release). But given that the fixed-dose combination pill combines two already marketed drugs - AstraZeneca's statin Crestor and Abbott's triglyceride-lowering medication TriLipix - it's likely the agency's concerns have more to do with efficacy than safety

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