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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...
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