BIOVAIL'S TRAMADOL ER RECEIVES FDA APPROVAL

The FDA has approved Biovail's new drug application for a once-daily formulation of Tramadol ER (tramadol HCl). The product has been approved for the treatment of moderate to moderately severe chronic pain in once-daily 100-, 200- and 300-mg dosage strengths. Biovail said it is actively involved in negotiations related to the commercialization of Tramadol ER by a strategic marketing partner. The company expects to conclude these negotiations soon, and anticipates the commercial launch of Tramadol ER to occur in early 2006.