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Roszet FDA Approval History

Last updated by Judith Stewart, BPharm on April 6, 2021.

FDA Approved: Yes (First approved March 23, 2021)
Brand name: Roszet
Generic name: ezetimibe and rosuvastatin
Dosage form: Tablets
Company: Althera Life Sciences, LLC
Treatment for: High Cholesterol, High Cholesterol, Familial Homozygous

Roszet (ezetimibe and rosuvastatin) is an intestinal cholesterol inhibitor and HMG Co-A reductase inhibitor (statin) combination indicated to reduce low-density lipoprotein cholesterol (LDL-C) in primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia (HoFH).

  • Ezetimibe is FDA approved under the brand name Zetia, and rosuvastatin is approved under the brand name Crestor. The combination therapy has been shown to significantly reduce LDL cholesterol beyond the statin alone.
  • Roszet tablets are taken once daily.
  • Common adverse reactions for rosuvastatin include headache, nausea, myalgia, asthenia, dizziness, asthenia, constipation, and abdominal pain. Common adverse reactions for ezetimibe co-administered with a statin include nasopharyngitis, myalgia, upper respiratory tract infection, arthralgia, diarrhea, back pain, influenza, pain in extremity, and fatigue.

Development timeline for Roszet

Mar 31, 2021Approval FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.