Label Changes for:

Lovaza (omega-3-acid ethyl esters) capsules

September 2009

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

CLINICAL PHARMACOLOGY

Drug-Drug Interactions
  • Simvastatin: In a 14-day study of 24 healthy adult subjects, daily co-administration of simvastatin 80 mg with Lovaza 4 grams did not affect the extent  (AUC) or rate (Cmax) of exposure to simvastatin or the major active metabolite, beta-hydroxy simvastatin at steadhttp://wcms.fda.gov/ucm/resources/wcm/sitestudio/y state.
  • Atorvastatin: In a 14-day study of 50 healthy adult subjects, daily co-administration of atorvastatin 80 mg with Lovaza 4 grams did not affect AUC or Cmax of exposure to atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin at steady state.
  •  Rosuvastatin: In a 14-day study of 48 healthy adult subjects, daily co-administration of rosuvastatin 40 mg with Lovaza 4 grams did not affect AUC or Cmax of exposure to rosuvastatin at steady state.
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