Published in Medical Letter on the CDC and FDA, September 11th, 2005
The advisory committee voted that the potential, but unquantified, risk for tardive dyskinesia would outweigh the benefits, as defined by the FDA, of metoclopramide hydrochloride in combination with naproxen sodium. The company received a "not approvable" letter from the FDA in May 2004.
"Based on a...
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