Bayer Promem
Executive Summary
FDA's Peripheral & Central Nervous System Drugs Advisory Committee will review metrifonate (NDA 20-914) for treatment of mild to moderate dementia of the Alzheimer's type on Jan. 27. The following day, the committee will review Immunex' Novantrone (mitoxantrone, NDA 21-120) for treatment of secondary progressive multiple sclerosis ("The Pink Sheet" Dec. 13, 1999, p. 22). The meeting begins at 8:00 a.m. at the Hilton in Gaithersburg, Md. on both days
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Bayer ProMem delayed again
Bayer and FDA agree to cancel Jan. 27 review of Alzheimer's therapy metrifonate by FDA's Peripheral & Central Nervous System Drugs Advisory Committee (1"The Pink Sheet" Jan. 3, In Brief). Bayer said there are outstanding issues that need to be resolved and that it is not sure whether the meeting will be rescheduled. Originally submitted in November 1997, the ProMem NDA was deemed "not approvable" by FDA in February 1999. An amendment was submitted Aug. 4, setting a February user fee goal date
Bayer ProMem delayed again
Bayer and FDA agree to cancel Jan. 27 review of Alzheimer's therapy metrifonate by FDA's Peripheral & Central Nervous System Drugs Advisory Committee (1"The Pink Sheet" Jan. 3, In Brief). Bayer said there are outstanding issues that need to be resolved and that it is not sure whether the meeting will be rescheduled. Originally submitted in November 1997, the ProMem NDA was deemed "not approvable" by FDA in February 1999. An amendment was submitted Aug. 4, setting a February user fee goal date
FDA Advisory Cmte. Material Disclosure To Debut With Bayer ProMem Review
Bayer's ProMem and Immunex' Novantrone will be the first drugs to have advisory committee information packages publicly released.