AMAG Pharma announces that the FDA accepted its submission to broaden the existing label for Feraheme to include the treatment of all adults with iron deficiency anemia; PDUFA 2/2/2018(16.55 )
The co announced that the U.S. Food and Drug Administration accepted its submission to broaden the existing label for Feraheme (ferumoxytol) to include the treatment of all adults with iron deficiency anemia who have an intolerance or unsatisfactory response to oral iron. The FDA has indicated a six-month review timeline and established a Prescription Drug User Fee Act target action date of February 2, 2018. The current indication of Feraheme is limited to the treatment of IDA in adults with chronic kidney disease.
AMAG Pharmaceuticals, Inc. is a pharmaceutical company. The Company's segment is the manufacture, development and commercialization of products and services for use in treating various conditions, with a focus on maternal health, anemia management and cancer supportive care. Its offerings focus on maternal health, anemia management and cancer supportive care, including its product, Makena (hydroxyprogesterone caproate injection); services related to the collection, processing and storage of umbilical cord blood stem cell and cord tissue units operated through Cord Blood Registry (CBR); its product, Feraheme (ferumoxytol), for intravenous (IV) use, and MuGard Mucoadhesive Oral Wound Rinse. It is engaged in the development of Digoxin immune fab, a polyclonal antibody for the treatment of severe preeclampsia in pregnant women. Makena is a drug indicated to reduce the risk of preterm birth in women pregnant with a single baby having a history of singleton spontaneous preterm birth.
Address
1100 Winter St
WALTHAM, MA 02451-1427
United States
WALTHAM, MA 02451-1427
United States
Website
http://www.amagpharma.comKey stats and ratios
| Q2 (Jun '17) | 2016 | |
| Net profit margin | -8.88% | -0.47% |
| Operating margin | -3.71% | 14.82% |
| EBITD margin | - | 37.42% |
| Return on average assets | -2.38% | -0.10% |
| Return on average equity | -6.03% | -0.27% |
| Employees | 545 |
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