AMU AMAG Pharmaceuticals Inc.

AMAG Pharmaceuticals Provides Update on FDA’s Proposal Regarding Makena® (Hydroxyprogesterone Caproate Injection)

AMAG Pharmaceuticals Provides Update on FDA’s Proposal Regarding Makena® (Hydroxyprogesterone Caproate Injection)
EN
06/10/2020

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Reports on AMAG Pharmaceuticals Inc.

 PRESS RELEASE

AMAG Pharmaceuticals Files Submission in Response To the Food And Drug...

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., Dec. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. has submitted its 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 have a h...

 PRESS RELEASE

AMAG Pharmaceuticals Requests Hearing to Maintain Makena® (Hydroxyprog...

AMAG Pharmaceuticals Requests Hearing to Maintain Makena® (Hydroxyprogesterone Caproate Injection) as a Treatment Option for Clinically Indicated Pregnant Patients WALTHAM, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena®, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by . A...

 PRESS RELEASE

AMAG Pharmaceuticals Provides Update on FDA’s Proposal Regarding Maken...

AMAG Pharmaceuticals Provides Update on FDA’s Proposal Regarding Makena® (Hydroxyprogesterone Caproate Injection)

 PRESS RELEASE

Covis Group Announces Agreement to Acquire AMAG Pharmaceuticals

Covis Group Announces Agreement to Acquire AMAG Pharmaceuticals

 PRESS RELEASE

AMAG Pharmaceuticals to Participate in H.C. Wainwright 22nd Annual Glo...

AMAG Pharmaceuticals to Participate in H.C. Wainwright 22nd Annual Global Investment Conference WALTHAM, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that Scott Myers, Chief Executive Officer, and Brian Piekos, Chief Financial Officer, will participate in a fireside chat at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 10:30 a.m. Eastern Time. A live audio webcast of the virtual event will be accessible through the Investors section of the company’s website at . A replay of the webcast...

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