Pozen migraine combo to get committee review
Executive Summary
Pozen's naproxen/metaclopramide migraine combination is slated to be reviewed by FDA's Peripheral & Central Nervous System Drugs Advisory Committee May 4, firm says. Committee will place "particular emphasis" on potential risk of metaclopramide-induced tardive dyskinesia, Pozen says. Decision to present drug to committee came after "series of meetings" with FDA; MT-100 was deemed "not approvable" in May 2004 due to both efficacy and safety concerns (1"The Pink Sheet" June 7, 2004, p. 37)...
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