Supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc. (Amarin), for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease

1) ) Overview of the research programs in the Laboratory of Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral Diseases (LVVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA

2) Recommendations on the selection of strains to be included in an influenza virus vaccine for the 2020 southern hemisphere influenza season

1) Pediatric-focused safety review of OxyContin (oxycodone)

2) Considerations for opioid analgesic pediatric studies and labeling

Pediatric-focused safety review of neuropsychiatric events with use of Singulair (montelukast)