AMAG PHARMACEUTICALS,INC. (NASDAQ:AMAG) Files An 8-K Other EventsItem 8.01. Other Events.
On February 5, 2018, AMAG Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration has approved its application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease indication to include all eligible adult iron deficiency anemia patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d)Exhibits
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ExhibitNo. |
Description |
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99.1 |
Press release, dated February 5, 2018
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AMAG PHARMACEUTICALS INC. ExhibitEX-99.1 2 ex9912518.htm EXHIBIT 99.1 Exhibit AMAG PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL NEW DRUG APPLICATION (sNDA) FOR FERAHEME ® (ferumoxytol injection) Feraheme is Now a Treatment Option for All Eligible Adult Patients with Iron Deficiency Anemia WALTHAM,…To view the full exhibit click here
About AMAG PHARMACEUTICALS,INC. (NASDAQ:AMAG)
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.
