FDAnews
www.fdanews.com/articles/108442-company-seeking-fda-approval-of-medicine-for-rare-genetic-disease

Company Seeking FDA Approval of Medicine for Rare Genetic Disease

July 10, 2008
The acquisition of Chenofalk is important not only to ensure continued supply in Germany, but Sigma-Tau Pharmaceuticals also intends to accumulate the appropriate clinical and regulatory documentation required to support the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the use of chenodeoxycholic acid (CDCA) in the treatment of Cerebrotendinous Xanthomatosis (CTX) disease.
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