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Biovail tramadol ODT approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biovail will select a trade name for its orally disintegrating tramadol (formerly Ralivia FlashDose) once it finds a marketing partner for the opioid analgesic, cleared May 5 for moderate to moderately severe pain in adults. Late-stage discussions with potential partners are underway, the firm said. Biovail also has an extended-release tramadol formulation (formerly Ralivia ER) pending, which has been "approvable" since October 2004. The firm expects to submit additional data in late 2005/early 2006 (1Pharmaceutical Approvals Monthly April 2005, In Brief)...

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