Safety Warning Letter Sample
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DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Marc Beer Chief Executive Officer Aegerion Pharmaceuticals, Inc.. 1 According to the INDICATIONS AND USAGE section of the FDA-approved product labeling (PI) for Juxtapid (emphasis original): JUXTAPID is indicated as an adjunct to a low-fat diet and other lipid lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-highdensity lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).. If you think about some oncology products that may lengthen life three months or six months, this product has the potential of taking a patient that would die at 30 and allow them to meet their grandkids.” On October 31, 2013, during another appearance on CNBC’s television show, you made additional statements with regard to Juxtapid, including: x “These patients are going to die of a cardiac event, either a stroke or a heart attack, if we don’t have them on therapy.” Reference ID: 3404255 Marc Beer Aegerion Pharmaceuticals, Inc..
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