Biovail submits citizen petition to FDA (BVF) 23.55 +0.45: -Update- Co announces the submission of a Citizen Petition with the FDA to require rigorous bioequivalence testing for generic products that reference Wellbutrin X.L before they can be approved. The co has taken this step to protect patients against potentially serious risks (particularly seizures) which are currently disclosed in the approved Wellbutrin X.L labeling, and to ensure that generic versions of Wellbutrin X.L are as safe and effective as the innovator product.
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