Amarin Corp Plc (AMRN)

[zumantu]

Thank you for writing to Dr. John Jenkins and Dr. Janet Woodcock at the Food and Drug Administration (FDA or the Agency) regarding the supplemental new drug application (sNDA) for Vascepa (icosapent ethyl), which is currently under review. Please accept this response from the Division of Drug Information on their behalf.

Your comments have been received and are greatly appreciated. Please know that FDA is making every effort to resolve the matter as expeditiously as possible, while also ensuring that the Agency’s decision reflects a full consideration of the issues brought to our attention in light of all the available scientific evidence.

Best regards,

CCL
Drug Information Specialist
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration