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Biovail Confirms Receipt of Notification of ANDA Submission for Wellbutrin XL.
Canadian Corporate News, November, 2004
TORONTO, Nov 17, 2004 (CCNMatthews via COMTEX)
Biovail Corporation (NYSE:BVF)(TSX:BVF) today confirmed that it has received notification that an abbreviated new drug application (ANDA) has been submitted to the U.S. Food and Drug Administration (FDA) by Anchen Pharmaceuticals, Inc., seeking marketing approval for 150mg and 300mg generic formulations of Wellbutrin XL(R) (once-daily bupropion). At the present time, it is not known if the ANDA submission has been accepted for review by the FDA.
In accordance with the relevant regulations, Biovail has a 45-day period in which to ...
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