Treximet
Generic name: sumatriptan succinate and naproxen sodium
Treatment for: Migraine
Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter
CHAPEL HILL, N.C., July 31, 2006 - POZEN Inc. announced today that they plan to submit a full response to the Approvable letter for Trexima during the fourth quarter of 2006. The full response will include additional safety information. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss and reach agreement on the proposed plan for responding to the Approvable letter. The FDA will have up to six-months to review the information contained in the full response.
Dr. John R. Plachetka, POZEN's chairman, president and chief executive officer stated, "We are very pleased to reach agreement with the FDA allowing us to make a full response in a timely manner."
Trexima is the proposed brand name for the combination of sumatriptan succinate, formulated with RT Technology(TM), and naproxen sodium, in a single tablet for the acute treatment of migraine.
Source: POZEN
Posted: July 2006
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Treximet (sumatriptan succinate and naproxen sodium) FDA Approval History
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