EFFICACY AND SAFETY OF WELLBUTRIN XL® COMPARED WITH OTHER ANTIDEPRESSANTS SUMMARY
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Wellbutrin XL® (bupropion HCl extended-release tablets) is a once-daily formulation of bupropion indicated for the treatment of major depressive disorder (MDD) in adults aged 18 and older. Wellbutrin XL and Lexapro® (escitalopram oxalate, Forest Labs) have been compared with respect to antidepressant efficacy, effects on sexual functioning, and safety in 2 randomized, double-blind, placebo-controlled trials. Wellbutrin SR® (bupropion HCl) Sustained-Release Tablets and Zoloft® (sertraline hydrochloride, Pfizer) have been proven comparably effective in treating depression and accompanying symptoms of anxiety in 3 double-blind, randomized, multicenter studies. Wellbutrin SR and Prozac® (fluoxetine HCl, Eli Lilly and Company) have been compared with respect to antidepressant efficacy, effects on sexual functioning, and safety in 2 randomized, doubleblind, placebo-controlled clinical trials. A randomized, double-blind, controlled, clinical trial comparing Wellbutrin® (bupropion HCl) Tablets and fluoxetine found both to be similarly efficacious for the treatment of depression and accompanying symptoms of anxiety. Treatment-emergent adverse events were also similar. Wellbutrin SR and Paxil® (paroxetine HCl, GlaxoSmithKline) were shown to be comparably effective in treating depression and accompanying symptoms of anxiety in elderly depressed patients in a double-blind, randomized, multicenter study. Wellbutrin has also been compared to various tricyclic antidepressants (TCAs) in double-blinded studies.
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Some information contained in this response may be outside the approved Prescribing Information for Wellbutrin XL. This response is not intended to offer recommendations for administering Wellbutrin XL in a manner inconsistent with its approved labeling. In order for GlaxoSmithKline to monitor the safety of Wellbutrin XL, we encourage healthcare