Cholesterol drug misbranded, company pleads guilty
Cholesterol drug misbranded, company pleads guiltyPharma maker pleads guilty that one of its major drugs was misbranded in a federal court case brought by FDA and the US Department of Justice.
FDA approves mipomersen sodium for HoFHFDA has approved mipomersen sodium (Kynamro, Genzyme and Isis Pharmaceuticals) once-a-week injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).