Amag’s Feraheme Label Application Reject by FDA

Amag Pharmaceuticals have received a setback for their anaemia drug, Feraheme, after the US Food and Drug Administration (FDA) rejected Amag’s application to expand the drug’s label. The regulatory agency issued a complete response letter for the supplemental New Drug Application to increase use of Feraheme (ferumoxytol) beyond the current chronic kidney disease indication, to

Continue Reading