Forest’s Namenda Gets “Not Approvable” Letter For Mild Alzheimer’s Indication
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm blames supplementary studies – which found numerical improvement for the memantine cohort but failed to meet statistical significance – for the denial.
You may also be interested in...
Forest Labs Aims To Launch Once-Daily Namenda Ahead Of Generics
Alzheimer's line-extension is in Phase III, and first ANDA with paragraph IV certification for current twice-daily formula could be filed next fall.
Forest Labs Aims To Launch Once-Daily Namenda Ahead Of Generics
Alzheimer's line-extension is in Phase III, and first ANDA with paragraph IV certification for current twice-daily formula could be filed next fall.
Pfizer/Eisai’s Aricept Becomes First Treatment Approved For All Degrees of Alzheimer’s
Because Aricept is often used in combination with Namenda, though, Forest says it is not concerned about market share erosion.