Par Pharma launches generic Ultram ER in US
This article was originally published in Scrip
Executive Summary
Par Pharmaceutical has gained final US FDA approval of its extended-release tramadol product in 100mg and 200mg strengths, a generic version of Ortho-McNeil's (Johnson & Johnson) once-daily Ultram ER. Following the approval on November 13th, Par immediately began shipping the analgesic, with the launch date marking the beginning of 180 days of exclusivity (granted as a result of its first-filer status).