Replies to post #76 on AMAG Pharmaceuticals (AMAG)

[surf1944]

2:01AM AMAG Pharma receives notice of 3-month extension of PDUFA date for supplemental NDA for Feraheme for broader IDA indication (AMAG) 19.54 : Co announces the FDA has extended its review of a supplemental new drug application for Feraheme injection for intravenous use. The sNDA seeks to expand the indication for Feraheme beyond the current indication for the treatment of iron deficiency anemia in adult patients with chronic kidney disease to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment. The new prescription drug user fee act action date has been set for January 21, 2014.