Neurochem Ltd.

Neurochem submits new drug application to U.S. FDA for Fibrillex for Amyloid A (AA) amyloidosis

Published in Pharma Law Weekly, March 21st, 2006

Neurochem Limited (NRMX; NRM) announces that the company has submitted to the U.S. Food & Drug Administration (FDA) the final modules of its new drug application (NDA) for eprodisate (Fibrillex) for the treatment of Amyloid A (AA) amyloidosis.

The submission completes this "rolling" NDA that was initiated in August 2005, under the continuous marketing application (CMA) pilot 1 program. The FDA agreed in June 2005 to file and review the NDA.

Dr. Francesco Bellini, chairman, president and chief executive officer said, "We believe that the NDA package supports the clinically and statistically meaningful effect of this product candidate on the...

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Source: Pharma Law Weekly (2006-03-21)

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