NDA Filed for Mixed Dyslipidemia Treatment

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Abbott (Abbott Park, Ill.) and AstraZeneca (London, UK) have submitted a New Drug Application (NDA) for an investigational drug to treat mixed dyslipidemia.

Pending approval of the NDA, the drug will be marketed as Certriad.

The treatment will contain the active ingredients of Crestor (rosuvastatin) and Trilipix (fenofibric acid), both FDA-approved medications.

Crestor is indicated as a dietary adjunct to reduce elevated total cholesterol, LDL, non-HDL cholesterol, apolipoprotein B, and triglycerides and to increase HDL in adult patients with primary hyperlipidemia or mixed dyslipidemia.

It also is indicated for slowing progression of atherosclerosis in adults as part of a treatment strategy to lower total cholesterol and LDL to target levels. Trilipix is a prescription medication used along with a low-fat and low-cholesterol diet in adults to lower triglycerides and LDL and to increase HDL.

“Patients with mixed dyslipidemia are an underserved segment of the dyslipidemic population,” said Eugene Sun, MD, Abbott's Vice President for Global Pharmaceutical Clinical Development.

“If approved, Certriad could become an important treatment option for physicians looking to provide comprehensive management of mixed dyslipidemia to their patients.”

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