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.
Lesen Sie auch
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.