Pain Therapy

FDA issues approvable letter for Ralivia ER

Published in Medical Letter on the CDC and FDA, December 19th, 2004

Biovail Corporation (BVF) announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Ralivia ER (tramadol hydrochloride) extended-release tablets, a once-daily oral controlled-release pain medication.

Biovail's NDA submission, which was accepted for review by the FDA in late February 2004, included clinical and safety data obtained from four original adequate and well-controlled trials involving more than 3000 patients who received doses of up to 400mg of Ralivia ER once daily.

The submission also included 12 definitive and five supportive pharmacokinetic studies which...

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Source: Medical Letter on the CDC and FDA (2004-12-19)

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