Pappas Capital LLC
09/23/2008 | Press release | Archived content
Anthera completes special protocol assessment with FDA and receiv...
News | 09. 23. 2008
Anthera Pharmaceuticals
Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Protocol Assessment procedure. At the same time, the company received Scientific Advice from the European Medicines Agency (EMEA) on Anthera's European development strategy for varespladib. Guidance from both regulatory agencies regarding varespladib will be incorporated into Anthera's global registration program slated to start next year.
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