MT 100 FDA Approval Status
MT 100 (metoclopramide hydrochloride and naproxen sodium) is an investigational antiemetic and nonsteroidal anti-inflammatory drug (NSAID) combination intended for use in the treatment of migraine.
In May 2004, Pozen Inc. announced receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for MT 100 had not been approved due to the risk of tardive dyskinesia associated with metoclopramide.
The company went on to receive FDA approval for MT 400, marketed as Treximet (sumatriptan and naproxen sodium), for the acute treatment of migraine attacks in April 2008.
Development Timeline for MT 100
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