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Biotechnology Business
Biovail Submits Complete Response to FDA for BVF-033
November 9th, 2007
Biovail Corporation (NYSE:BVF) (TSX:BVF) announced that the Company has submitted a Complete Response to the United States Food and Drug Administration (FDA) that addresses all the issues raised in the Non-Approval Letter for BVF-033, a novel once-daily salt formulation of bupropion. Based on Biovail's discussions with the FDA in an August 14, 2007 meeting, and in accordance with FDA feedback, the submission includes new analyses of the data included in the original New Drug Application (NDA) for BVF-033, but does not include results from any new studies. Biovail anticipates receiving a response from the FDA in the near term. The Company believes the data package is...
Source: Biotech Law Weekly (2007-11-09)
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