AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw Approval of Makena® (hydroxyprogesterone caproate injection)

WALTHAM, Mass., December 14, 2020 – AMAG Pharmaceuticals, Inc. has submitted its response to the FDA’s Notice of Opportunity for a Hearing (“NOOH”) regarding the Agency’s proposal to withdraw approval for Makena—also referred to as 17-OHPC—the only FDA-approved treatment, along with five generic versions, to reduce preterm birth in women with a singleton pregnancy who… More

A message to healthcare providers, staff and patients:

During this time of heightened concern regarding COVID-19, we want to provide you with timely updates on our plans to do our part and share the steps we’re taking to ensure healthcare providers and patients continue to receive uninterrupted support from AMAG Pharmaceuticals. We are focused on keeping employees and our communities safe and have… More

AMAG Files Response to Citizen Petition

Today, AMAG Pharmaceuticals, Inc. submitted its response https://www.regulations.gov/document?D=FDA-2019-P-4683-0005 with the U.S. Food and Drug Administration (FDA) to a petition filed by Public Citizen’s Health Research Group (HRG). AMAG respectfully disagrees with HRG’s request to withdraw FDA approval of Makena® (hydroxyprogesterone caproate injection) and the five FDA-approved generics (which could no longer be marketed if Makena’s NDA… More

Makena® (hydroxyprogesterone caproate injection) Approval and Product Label Remain Unchanged

The U.S. Food and Drug Administration’s (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee’s recommendation on October 29, 2019 has led to some confusion in the healthcare community about the current status of Makena. At this time, it is important to know that Makena’s approval and product label remain unchanged. You may learn more about… More

AMAG Pharmaceuticals Announces Settlement Agreement with Caligan Partners LP

Paul Fonteyne and David Johnson Join Board of Directors WALTHAM, Mass., October 8, 2019 – AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) (“AMAG”) today announced that it has entered into a settlement agreement with Caligan Partners LP (“Caligan”). As part of this agreement, the Board of Directors has appointed Paul Fonteyne, former Chief Executive Officer of Boehringer… More

Preeclampsia Foundation welcomes AMAG Pharmaceuticals as Corporate Partner

The Preeclampsia Foundation and AMAG Pharmaceuticals, Inc. today announced a Corporate Partnership focused on the ongoing commitment of both organizations to improve the diagnosis and treatment of hypertensive disorders of pregnancy, including preeclampsia, eclampsia, and HELLP syndrome. “We appreciate AMAG Pharmaceuticals’ support of our efforts as a Corporate Partner,” said Eleni Tsigas, Chief Executive Officer… More

AMAG PHARMACEUTICALS CEO, WILLIAM HEIDEN, TO LEAD MARCH FOR BABIES AS 2019 BOSTON CHAIR

BOSTON, MA March 11, 2019 — The Massachusetts Market of March of Dimes today announced that business and community leader William Heiden, president and chief executive officer AMAG Pharmaceuticals, Inc. has been selected to serve as the March for Babies event chair for the upcoming Boston walk on May 11, 2019. “I’m honored to chair… More

AMAG’s Kathryn Payne Joins MassBio® Board of Directors

AMAG Pharmaceuticals is pleased to announce that Kathryn Payne, Senior Vice President, Corporate Affairs, has been appointed to the Massachusetts Biotechnology Council (MassBio) board of directors. Founded in 1985, MassBio is a not-for-profit organization that represents and provides services and support for more than 1,000 organizations involved in life sciences and healthcare in Massachusetts. “AMAG… More

AMAG Wins Innovation SABRE Award for Health in Bloom Experience at 2017 American College of Obstetricians and Gynecologists Annual Meeting

Visually Disruptive, Three Dimensional Rose Vulva Promoting Vaginal Health and Wellness Recognized for Cutting Edge Approach AMAG Pharmaceuticals, together with its agency partner, Marina Maher Communications received a SABRE Innovation award from the Holmes Report on February 13, 2018, for the Health in Bloom interactive rose sculpture at the 2017 American College of Obstetricians… More

AMAG Works with Leaders in Maternal and Infant Health to Launch the Pregnancy & Baby Health Clearinghouse Website

Nearly one in ten babies is born premature in the United States, potentially resulting in long-term health and developmental challenges.[i] Despite efforts to improve health and well-being for mothers and babies, critical gaps in progress remain. Among these is the persistent presence of major health inequities in the prevention of preterm birth among minorities, particularly… More