Clinical Trial Research

FDA Issues Second Approvable Letter for Trexima

Published in Medicine and Law Weekly, August 17th, 2007

POZEN Inc. (NASDAQ:POZN) and GlaxoSmithKline (NYSE:GSK) announced that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for Trexima(TM) (sumatriptan/naproxen sodium). An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing approval.

In January 2007, POZEN and GSK responded to the FDA's first approvable letter, submitting additional safety data from clinical trials, data from GSK's database, and additional in vitro preclinical data. In the second approvable letter, no additional information regarding the cardiovascular safety of Trexima was...

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Source: Medicine and Law Weekly (2007-08-17)

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