Jul 22, 2008 - Xanodyne Pharmaceuticals, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zipsor, its candidate for the treatment of patients with mild to moderate acute pain. Zipsor is a proprietary immediate release liquid-filled soft gelatin capsule containing 25 mg of diclofenac potassium for oral administration.
"Xanodyne is pleased with this action and will work closely with the FDA to provide a complete response. Importantly, no additional clinical trials have been requested," said Gregory D. Flexter, President and Chief Executive Officer of Xanodyne. Zipsor is a unique formulation designed for rapid and consistent release while minimizing systemic exposure.
The details can be read here.
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