Title

Fluoxetine

Date

December 1987

Document Type

Article

Publisher

United States. Food and Drug Administration.

Description

Study 19 - This was a small study (N=46 for fluoxetine and placebo combined), but it was statistically significant with a p-value of .011, according to the FDA. Study 25 - This study was negative according to the FDA (it performed numerically worse than placebo), but it was presented as positive in the journal article listed below. For details, see NEJM article. supplemental appendix Table B. Study 27 - This is a moderately large study (N=344 for the two groups combined) that showed a significant difference between fluoxetine and placebo. Study 62 - Although it may appear that Study #62 is a single study, there were in fact two (2) separate studies, 62-a and 62-b, identical in design. Study #62-a, published in Dunlop, et al., was nonsignificant at all three doses of fluoxetine and was thus considered a negative study by the FDA. Study #62-b, published in Wernicke, et al., was significant at 2 of the 3 doses studied and was considered positive by the FDA.

Identifier

doi:10.6083/M41C1VJT

Note

New Drug Application Number: 1987-12-29

Brand name: 18-936

Generic Drug Name: Prozac

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