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Namenda "not approvable" for mild-moderate Alzheimer’s

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Forest's Namenda (memantine) is "not approvable" for treatment of mild-to-moderate Alzheimer's disease, the firm says July 25. Two studies failing to show statistical significance led FDA to deny the indication. The sNDA included a third study showing statistical significance, but "FDA decided not to approve Namenda for mild patients based upon this single positive study in light of two previously disclosed, additional studies," Forest said. Namenda would have been the first AD agent approved for the full continuum of the disease. J&J's Risperdal (risperidone) also was deemed not approvable recently for an Alzheimer's-related indication (1Pharmaceutical Approvals Monthly June 2005, p. 13)...

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