Published in Medical Letter on the CDC and FDA, February 11th, 2007
These findings will serve as the basis for a New Drug Application (NDA) for PRO-513, expected to be filed with the U.S. Food and Drug Administration in early 2007.
In an eight month randomized, double-blind, placebo-controlled trial that enrolled 690 adult patients, PRO-513, a proprietary formulation of diclofenac potassium powder for oral solution, reached all of its primary endpoints by achieving statistical superiority to placebo in pain relief (p greater than 0.001) and the associated...
Want to see the full article?
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA