Biovail Wellbutrin XL user fee
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
New user feel goal date for Biovail's Wellbutrin XL is Sept. 3 following "complete response" to June 25 "approvable" letter. An NDA for the once-daily formulation of the extended-release antidepressant bupropion was submitted Aug. 26, 2002...