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FDA Approves Crestor for Primary Dysbetalipoproteinemia

Crestor Approved for Primary Dysbetalipoproteinemia

November 6, 2008 - The United States Food and Drug Administration has approved an additional indication for Crestor.

Crestor is now approved for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipoproteinemia) as an adjunct to diet.

Crestor (rosuvastatin calcium) is an HMG Co-A reductase inhibitor first approved in 2003. Crestor is also indicated for

  • patients with primary hyperlipidemia and mixed dyslipidemia as anadjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, andTG levels and to increase HDL-C
  • patients with hypertriglyceridemia as an adjunct to diet
  • patients with primary dysbetalipoproteinemia (Type IIIhyperlipoproteinemia) as an adjunct to diet
  • patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB
  • slowing the progression of atherosclerosis as part of a treatment strategy tolower total-C and LDL-C as an adjunct to diet.

For more information on Crestor, please see Crestor Information for Professionals at

Posted: November 2008

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