POZEN, Inc.

Trexima NDA accepted for review by U.S. Food and Drug Administration

Published in Biotech Law Weekly, November 11th, 2005

GlaxoSmithKline (GSK) and POZEN, Inc., (POZN), announced that the new drug application (NDA) for Trexima has been accepted for review by the U.S. Food & Drug Administration (FDA).

Trexima is the proposed brand name for the combination of sumatriptan succinate, formulated with RT Technology, and naproxen sodium, in a single tablet for the acute treatment of migraine. The NDA seeking marketing approval in the U.S. was submitted on August 8, 2005. Pending FDA approval, the product could be available to patients as early as second-half 2006.

"The Trexima NDA acceptance is an important milestone for POZEN," stated Dr. John Plachetka, POZEN's chairman,...

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Source: Biotech Law Weekly (2005-11-11)

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