Published in Medical Letter on the CDC and FDA, September 4th, 2005
This amendment is intended to provide a complete response to the approvable letter received in October 2003, based on results from the recently completed Evaluation of Ranolazine In Chronic Angina (ERICA) study, which was conducted under the FDA's special protocol assessment (SPA) process and met its primary endpoint.
The NDA, if approved, could enable the potential launch of Ranexa in...
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