Abbott and AZ submit NDA for Certriad to US FDA
US health care major Abbott Laboratories and Anglo-Swedish drug major AstraZeneca have submitted a New Drug Application to the US Food and Drug Administration for Certriad, an investigational compound for the treatment of mixed dyslipidemia combining AZ's cholesterol lowerer Crestor (rosuvastatin calcium) and Abbott's TriLipix (fenofibric acid).
The targeted indication involves two or more lipid abnormalities including high low-density lipoprotein cholesterol, high triglycerides and low high-density lipoprotein-cholesterol.
The NDA submission is supported by data from multiple studies, including efficacy and safety trials with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid, the firms noted. The drug is the latest development under the two companies' cardiovascular alliance.
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