MHLW Lifts Conditions On Banyu's Hyperlipidemia Drug Lipovas
This article was originally published in PharmAsia News
Executive Summary
The first section on drugs of the Pharmaceutical Affairs and Food Sanitation Council at the Ministry of Health, Labor and Welfare lifted conditions on Banyu Pharmaceutical's hyperlipidemia drug Lipovas (simvastatin). Imposed upon approval in 2001, the conditions required Banyu to study the relationship between increased dosage and the onset of rhabdomyolysis, but no cases of rhabdomyolysis have been reported and creatine kinase counts, directly related to the disease, are lower after market launch compared to those reported in clinic trials. (Click here for more - Japanese language)