Endo Pharmaceuticals and Vernalis have received a "not approvable" letter for an additional indication for its migraine medicine Frova. The companies had hoped to gain an approval for menstrual migraines, but the FDA called the sNDA weak, and questioned whether trial results were clinically significant for menstrual migraine. "The FDA raised a number of issues that will need to be fully analyzed and then discussed with the FDA. Following this discussion with the FDA, Endo and Vernalis will decide upon the appropriate course of action," stated Peter A. Lankau, Endo President and CEO.
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