Biovail Corporation (BVF) Updates Status Of NDA For Tramadol ER; Additional Clinical Trial Data Will Be Required
10/19/2005 5:13:09 PM
TORONTO--(BUSINESS WIRE)--March 30, 2005--Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that it has received comments from the United States 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.
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 six-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 Response fully support 505(b)(2) filing requirements, and the Company is considering a number of options. Biovail expects to meet with the FDA to discuss these options promptly. In the meantime, however, Biovail will immediately undertake a clinical program to address the FDA's comments. Biovail anticipates the submission of new clinical data in late 2005 or early 2006. Biovail believes that a new six-month review period would then be initiated.