Key Developments For AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. (AMAG.O) (Consolidated Issue listed on NASDAQ Global Market)
AMAG Pharmaceuticals, Inc. Receives Complete Response Letter From FDA for Ferumoxytol
AMAG Pharmaceuticals, Inc. 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 that no additional clinical trials will be required for approval. The FDA indicated in its letter that the following additional information is required prior to granting approval of ferumoxytol: data to clarify a specific chemistry, manufacturing and controls (CMC) question; resolution of the deficiencies observed during the pre-approval inspection of the Company's manufacturing facility; and finalization of labeling discussions with the FDA.
AMAG Pharmaceuticals, Inc. Announces Ferumoxytol Resubmission Designated Complete
AMAG Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated the Company's resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date. AMAG is seeking marketing approval for ferumoxytol for the treatment of iron deficiency anemia in patients with all stages of chronic kidney disease (CKD), including those on dialysis and those not on dialysis.
AMAG Pharmaceuticals, Inc. Receives Complete Response Letter From FDA For Ferumoxytol
AMAG Pharmaceuticals, Inc. 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 Company believes that it can address the issues raised by the FDA in its complete response letter in a timely manner without conducting any additional clinical trials prior to approval. In addition, the Company continues preparations for the intended commercial launch of ferumoxytol during the first quarter of 2009. The Company submitted its New Drug Application for marketing approval of ferumoxytol in December 2007. Ferumoxytol, the Company's key product candidate, is being developed for use as an intravenous iron replacement therapeutic agent for the treatment of iron deficiency anemia and as a diagnostic agent for vascular enhanced magnetic resonance imaging to assess peripheral arterial disease.
AMAG Pharmaceuticals, Inc. Receives Fast Track Designation For Ferumoxytol For Vascular-Enhanced Magnetic Resonance Imaging
AMAG Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ferumoxytol for its development as a diagnostic agent for Vascular-Enhanced Magnetic Resonance Imaging (VE-MRI) to improve the assessment of peripheral arterial disease in patients with known or suspected chronic kidney disease (CKD). If approved for an imaging indication, ferumoxytol could offer an alternative to gadolinium-based contrast agents, which are required to contain a black box warning highlighting the risks of using gadolinium-based agents in patients with advanced kidney disease.
AMAG Pharmaceuticals, Inc. Announces Presentation of Positive Results from Phase III Studies of Ferumoxytol
AMAG Pharmaceuticals, Inc. announced positive results from pooled data from two open-label, multicenter, randomized Phase III studies of ferumoxytol as an intravenous iron replacement therapeutic agent.
