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MT 100 FDA Approval Status

FDA Approved: No
Brand name: MT 100
Generic name: metoclopramide hydrochloride and naproxen sodium
Company: Pozen Inc.
Treatment for: Migraine

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

Aug  5, 2005POZEN Provides Results of FDA Advisory Committee Meeting on MT 100 (Naproxen Sodium and Metoclopramide Hydrochloride)
Jun 29, 2005FDA Sets August 4, 2005 for Advisory Committee Meeting to Consider Tardive Dyskinesia Risk with MT 100
Dec 21, 2004POZEN's MT 100 To Be Reviewed by Advisory Committee in May 2005

Further information

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