GlaxoSmithKline Wellbutrin XL filing
This article was originally published in Pharmaceutical Approvals Monthly
GSK submits NDA for once-daily Wellbutrin XL Aug. 26, in advance of generic competition to Wellbutrin SR, its twice-daily bupropion formulation. Andrx' generic is awaiting final approval from FDA pending agreement on methodology for blend uniformity. GSK is appealing a Miami federal court ruling of non-infringement. The once-daily, extended-release formulation of bupropion was licensed from Biovail in October 200
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