POZEN Demonstrates Bioequivalence To Enteric Coated Aspirin For PA32540
POZEN Inc. (NASDAQ:POZN), announced that is has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for its pivotal Phase 3 trials for PA32540. The company had previously met with the FDA to discuss the overall development program requirements. As part of the SPA submission, the company has provided data indicating that PA32540 is bioequivalent to 325mg enteric coated aspirin.
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Filed under: Cardiovascular on June 11th, 2008