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Certriad FDA Approval Status

FDA Approved: No
Brand name: Certriad
Generic name: rosuvastatin calcium and fenofibric acid
Company: Abbott and AstraZeneca
Treatment for: High Cholesterol, Hypertriglyceridemia, Hyperlipoproteinemia

Certriad (rosuvastatin calcium and fenofibric acid) is a combination of the active ingredients in Crestor and Trilipix intended for the treatment of mixed dyslipidemia.

In March 2010, AstraZeneca and Abbott announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for Certriad (rosuvastatin/fenofibric acid delayed release) capsules had not been approved.

Development timeline for Certriad

Dec 22, 2010Abbott and AstraZeneca End License Agreement for the Development of Certriad
Mar 30, 2010AstraZeneca and Abbott Receive FDA Complete Response Letter on Certriad New Drug Application
Jun  4, 2009Abbott and AstraZeneca Submit New Drug Application to the FDA for Certriad, an Investigational Treatment for Mixed Dyslipidemia

Further information

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