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     143  0 Kommentare AMAG Pharmaceuticals Requests Hearing to Maintain Makena (Hydroxyprogesterone Caproate Injection) as a Treatment Option for Clinically Indicated Pregnant Patients - Seite 2

    ACOG issued a statement in response to FDA’s proposed withdrawal, noting that the need for an effective preterm birth treatment is great. As ACOG further recognized, Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition. ACOG states that their treatment recommendations remain unchanged at this time.

    ABOUT AMAG
    AMAG is a commercial-stage biopharmaceutical company focused on bringing innovative products to patients with unmet medical needs. The company does this by leveraging its development and commercial expertise to invest in and grow its pharmaceutical products across a range of therapeutic areas. For additional company information, please visit www.amagpharma.com.

    Forward Looking Statements
    This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding plans to submit, and expectations for, supporting documentation to the FDA; beliefs that it is in the best interest of patients to allow access to Makena; beliefs about maternal and infant health disparities among minority communities and the return to compounded versions of Makena, and that there are no other evidence-based options; beliefs, including beliefs attributed to other groups, in Makena’s efficacy for those at risk, including that further study should be undertaken into the efficacy of Makena before taking action to withdraw the product from the market and the ability of AMAG’s efforts to preserve patient access to Makena; expectations for working towards formulating and implementing appropriate study parameters to be undertaken to confirm Makena’s efficacy after the tender offer and merger transaction between Covis and AMAG closes, and expectations for the recently announced tender offer and merger transaction are based on management’s current expectations and beliefs and are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

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    AMAG Pharmaceuticals Requests Hearing to Maintain Makena (Hydroxyprogesterone Caproate Injection) as a Treatment Option for Clinically Indicated Pregnant Patients - Seite 2 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 …