Toronto - Biovail Corp. (NYSE:BVF; TSX:BVF) announced that its New Drug Application (NDA) for a once-daily formulation of tramadol hydrochloride (Tramadol ER) has received final approval from the FDA.
Tramadol ER has been approved for the treatment of moderate to moderately severe chronic pain in once-daily 100mg, 200mg and 300mg dosage strengths. Biovail is the first and only company to submit an application to the FDA for review, and to receive an approval for a once-daily tramadol formulation.
Biovail is actively involved in negotiations related to the commercialization of Tramadol ER by a strategic marketing partner. The …
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