11/20/2007 11:17:18 AM
TORONTO--(BUSINESS WIRE)--Biovail Corporation (NYSE:BVF)(TSX:BVF) today confirmed that the U.S. Food and Drug Administration (FDA) has classified the response submitted by the Company October 23, 2007, to the FDA Action Letter for BVF-033, its novel salt formulation of bupropion, as Class 2.
A Class 2 response is subject to a six-month review period by the FDA. A PDUFA date of April 23, 2008, has been set for receipt of the FDA’s decision.
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