Biovail tramadol “approvable”
Executive Summary
Biovail's NDA for orally disintegrating tramadol tablet is "approvable" at FDA pending resolution of labeling issues, including final agreement on a trade name, Biovail said Jan. 12. Working name has been Ralivia ODT. A previous "approvable" letter for Ralivia ER, an extended-release version of the analgesic, requested additional clinical information...