FDA 483 - Supernus Pharmaceuticals, Inc. - February 03, 2017

Supernus Pharmaceuticals, Inc. in Rockville, MD, was inspected regarding its analytical laboratory operations. The inspection revealed a significant issue with the timely submission of quarterly periodic adverse drug experience reports (PSURs) for its products Trokendi XR and Oxtellar XR. Approximately 40% of all PSURs for these products were submitted late to the FDA.