Abbott and AstraZeneca announced that they have submitted a New Drug Application (NDA) to the FDA for Certriad for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL- cholesterol, high triglycerides and low HDL-cholesterol. Certriad is an investigational compound containing the active ingredients of Crestor (rosuvastatin calcium) and Trilipix (fenofibric acid). The NDA submission includes data from multiple efficacy and safety studies with the 5mg, 10mg, and 20mg doses of rosuvastatin combined with fenofibric acid. Phase 3 studies were designed to evaluate the effect of Certriad on HDL and triglycerides compared to rosuvastatin monotherapy and the effect on LDL compared to fenofibric acid monotherapy in patients with mixed dyslipidemia.
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