Biovail Corporation

Status of NDA for Tramadol ER updated

Published in Lab Business Week, May 1st, 2005

Biovail Corporation (BVF) announced that it has received comments from the U.S. Food and Drug Administration (FDA) with regard to its New Drug Application (NDA) for Tramadol ER, an extended-release, once-daily formulation of tramadol hydrochloride for pain.

The FDA has acknowledged that Biovail's Complete Response to the Tramadol ER Approvable Letter is a Class 2 response, which is therefore subject to a 6-month review. The FDA has also advised that, upon preliminary review, it is of the opinion that additional clinical trial data will be required.

Biovail's view is that the clinical data contained within the original NDA and the March 2005 Complete...

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Source: Lab Business Week (2005-05-01)

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