Imitrex/Naproxen NDA Slated For 2005
This article was originally published in The Pink Sheet Daily
Executive Summary
GlaxoSmithKline and Pozen expect to submit an NDA for the acute migraine therapy sumatriptan/naproxen in the second half of 2005
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Pozen’s Migraine Agent To Be Focus Of FDA Advisory Committee Review
Naproxen/metoclopramide combination is expected to be reviewed by the Peripheral & Central Nervous System Drugs Advisory Committee May 4. Potential risk of tardive dyskinesia is expected to be discussed. FDA deemed MT-100 “not approvable” earlier this year.
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