AMAG Pharmaceuticals Receives Complete Response Letter from the FDA for Ferumoxytol (Centre Daily Times)
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ferumoxytol for the treatment of iron deficiency anemia in chronic kidney disease patients. The letter was received following the Company s Class 1 resubmission in response to an October 2008 Complete Response letter. The Company believes ...

Akorn, Inc. Responds To FDA Draft Guidance For Industry On Bioequivalence Recommendation For Vancomycin HCl (Medical News Today)
Akorn, Inc. (NASDAQ: AKRX) provided the following response regarding FDA's draft guidance on vancomycin hydrochloride (HCl) capsules. The Food and Drug Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) for vancomycin HCl capsules.