doi:10.6083/M4H9949P

This collection contains documents from Drug Approval Packages generated by the US Food and Drug Administration (FDA). The collection currently contains documents regarding seven drug classes

  1. Antipsychotics
  2. Antidepressants
  3. General anxiety disorder
  4. Obsessive compulsive disorder
  5. Panic disorder
  6. Post traumatic stress disorder
  7. Social anxiety disorder
Antipsychotic Agents
doi:10.6083/M4CJ8CKZ

The FDA review documents made available in this digital repository formed the basis for an article entitled Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database. Eight second-generation antipsychotic drugs are covered. The Drug Approval Package for one of the drugs (risperidone) is not available for download from the FDA website Drugs@FDA, but it is available here.

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Aripiprazole medical review, United States. Food and Drug Administration.

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Aripiprazole statistical review, United States. Food and Drug Administration.

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Iloperidone adminstrative correspondence, United States. Food and Drug Administration.

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Iloperidone approval letter, United States. Food and Drug Administration.

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Iloperidone medical review, United States. Food and Drug Administration.

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Iloperidone not approvable letter, United States. Food and Drug Administration.

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Iloperidone Office Director memo, United States. Food and Drug Administration.

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Iloperidone statistical review, United States. Food and Drug Administration.

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Iloperidone summary review (Division Director), United States. Food and Drug Administration.

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Olanzapine complete Drug Approval Package (all reviews), United States. Food and Drug Administration.

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Quetiapine medical review, United States. Food and Drug Administration.

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Quetiapine statistical review, United States. Food and Drug Administration.

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Risperidone Consta complete Drug Approval Package (all reviews), United States. Food and Drug Administration.

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Risperidone immediate release complete Drug Approval Package (all reviews), United States. Food and Drug Administration.

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Ziprasidone medical review, United States. Food and Drug Administration.

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Ziprasidone statistical review, United States. Food and Drug Administration.

Antidepressive Agents doi:10.6083/M47S7MV7

The reviews of the antidepressant drugs formed the basis for an article published by Dr. Erick Turner entitled Selective publication of antidepressant trials and its influence on apparent efficacy. Of the 12 drugs covered in that article, 8 drugs' reviews are included in this collection. Drug Approval Packages for the 4 remaining drugs can be downloaded from the FDA website.

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Bupropion SR, United States. Food and Drug Administration.

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Fluoxetine, United States. Food and Drug Administration.

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Mirtazapine, United States. Food and Drug Administration.

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Nefazodone, United States. Food and Drug Administration.

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Paroxetine, United States. Food and Drug Administration.

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Sertraline, United States. Food and Drug Administration.

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Venlafaxine, United States. Food and Drug Administration.

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Venlafaxine XR, United States. Food and Drug Administration.

General Anxiety Disorder doi:10.6083/M4416W47

The reviews of general anxiety disorder drugs formed the basis for an article published by Dr. Erick Turner entitled .

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Duloxetine hydrochloride, United States. Food and Drug Administration.

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Escitalopram oxalate, United States. Food and Drug Administration.

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Venlafaxine hydrochloride, United States. Food and Drug Administration.

Obsessive Compulsive Disorder doi:10.6083/M40864CF

The reviews of obsessive compulsive disorder drugs formed the basis for an article published by Dr. Erick Turner entitled .

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Fluoxetine hydrochloride, United States. Food and Drug Administration.

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Fluvoxamine maleate, United States. Food and Drug Administration.

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Sertraline hydrochloride, United States. Food and Drug Administration.

Panic Disorder doi:10.6083/M4M32TVB

The reviews of panic disorder drugs formed the basis for an article published by Dr. Erick Turner entitled .

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Fluoxetine hydrochloride, United States. Food and Drug Administration.

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Sertraline hydrochloride, United States. Food and Drug Administration.

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Venlafaxine hydrochloride, United States. Food and Drug Administration.

Post Traumatic Stress Disorder doi:10.6083/M4VH5MX6

The reviews of post traumatic stress disorder drugs formed the basis for an article published by Dr. Erick Turner entitled .

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Sertraline hydrocholride, United States. Food and Drug Administration.

Social Anxiety Disorder doi:10.6083/M4QV3KKR

The reviews of social anxiety disorder drugs formed the basis for an article published by Dr. Erick Turner entitled .

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Fluvoxamine maleate, United States. Food and Drug Administration.

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Paroxetine hydrochloride CR, United States. Food and Drug Administration.

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Sertraline hydrochloride, United States. Food and Drug Administration.

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Venlafaxine hydrochloride XR, United States. Food and Drug Administration.

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Articles

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Aripiprazole medical review, United States. Food and Drug Administration.

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Aripiprazole statistical review, United States. Food and Drug Administration.

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Bupropion SR, United States. Food and Drug Administration.

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Duloxetine hydrochloride, United States. Food and Drug Administration.

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Escitalopram oxalate, United States. Food and Drug Administration.

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Fluoxetine, United States. Food and Drug Administration.

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Fluoxetine hydrochloride, United States. Food and Drug Administration.

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Fluoxetine hydrochloride, United States. Food and Drug Administration.

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Fluvoxamine maleate, United States. Food and Drug Administration.

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Fluvoxamine maleate, United States. Food and Drug Administration.

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Iloperidone adminstrative correspondence, United States. Food and Drug Administration.

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Iloperidone approval letter, United States. Food and Drug Administration.

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Iloperidone medical review, United States. Food and Drug Administration.

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Iloperidone not approvable letter, United States. Food and Drug Administration.

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Iloperidone Office Director memo, United States. Food and Drug Administration.

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Iloperidone statistical review, United States. Food and Drug Administration.

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Iloperidone summary review (Division Director), United States. Food and Drug Administration.

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Mirtazapine, United States. Food and Drug Administration.

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Nefazodone, United States. Food and Drug Administration.

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Olanzapine complete Drug Approval Package (all reviews), United States. Food and Drug Administration.

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Paliperidone medical review, United States. Food and Drug Administration.

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Paliperidone statistical review, United States. Food and Drug Administration.

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Paroxetine, United States. Food and Drug Administration.

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Paroxetine hydrochloride, United States. Food and Drug Administration.

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Paroxetine hydrochloride CR, United States. Food and Drug Administration.

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Quetiapine medical review, United States. Food and Drug Administration.

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Quetiapine statistical review, United States. Food and Drug Administration.

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Risperidone Consta complete Drug Approval Package (all reviews), United States. Food and Drug Administration.

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Risperidone immediate release complete Drug Approval Package (all reviews), United States. Food and Drug Administration.

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Sertraline, United States. Food and Drug Administration.

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Sertraline hydrochloride, United States. Food and Drug Administration.

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Sertraline hydrochloride, United States. Food and Drug Administration.

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Sertraline hydrochloride, United States. Food and Drug Administration.

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Sertraline hydrocholride, United States. Food and Drug Administration.

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Venlafaxine, United States. Food and Drug Administration.

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Venlafaxine hydrochloride, United States. Food and Drug Administration.

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Venlafaxine hydrochloride, United States. Food and Drug Administration.

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Venlafaxine hydrochloride XR, United States. Food and Drug Administration.

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Venlafaxine XR, United States. Food and Drug Administration.

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Ziprasidone medical review, United States. Food and Drug Administration.

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Ziprasidone statistical review, United States. Food and Drug Administration.