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Home » FDA Rejects Novo Hemophilia Treatment Again Due to Manufacturing Issues
FDA Rejects Novo Hemophilia Treatment Again Due to Manufacturing Issues
August 9, 2013
Novo Nordisk struck out again with the FDA, which, for the second time, declined the Danish drugmaker’s BLA for a recombinant factor XIII (rFXIII) compound to treat hemophilia. According to Novo, manufacturing issues at one of its plants are to blame.