Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD™, An Investigational Treatment For Mixed Dyslipidemia
Abbott Park, Illinois (NYSE: ABT) and London, UK - Abbott and AstraZeneca announced that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL- cholesterol (the "bad" cholesterol), high triglycerides and low HDL-cholesterol (the "good" cholesterol). The NDA submission for this investigational compound, containing the active ingredients of CRESTOR® (rosuvastatin calcium) and TRILIPIX® (fenofibric acid), is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as CERTRIAD™.
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