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Http://www.accessdat A.fda.gov/drugsatfda _docs/nda/2007/02143 6s018_StatR.pdf

021436s018_StatR.pdf
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📄 Pages: 24 pages
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Summary

The FDA's Center for Drug Evaluation and Research conducted a statistical review of a supplemental New Drug Application (sNDA) for Abilify (aripiprazole) as an adjunctive treatment for major depressive disorder. The review included two clinical studies, 138139 and CN138163, which evaluated the efficacy and safety of Abilify in patients with major depressive disorder. The statistical review assessed the studies' design, efficacy measures, patient disposition, and demographic and baseline characteristics. The reviewer's results and conclusions were presented, along with an evaluation of safety and findings in special/subgroup populations. The review prioritized the application, with a PDUFA due date of November 16, 2007.

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Description

The FDA's Center for Drug Evaluation and Research conducted a statistical review of a supplemental New Drug Application (sNDA) for Abilify (aripiprazole) as an...

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  • File Format: PDF
  • File Size: 613 KB
  • Pages: 24
  • Language: EN
  • Total Downloads: 23
  • Last Updated: 2 months ago

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