AMAG Pharmaceuticals Inc

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U.S. FDA's Center For Drug Evaluation And Research Proposes Withdrawal Of Approval For Makena

Published: 10/05/2020 17:19 GMT
AMAG Pharmaceuticals Inc (AMAG) - :u.s. FDA's Center for Drug Evaluation and Research (cder) Proposes Withdrawal of Approval for Makena.
U.S. FDA Says Cder Proposed Makena's Withdrawal From the Market Because Required Postmarket Study Failed to Verify Clinical Benefit.
U.S. FDA Says Cder Concluded That Available Evidence Does Not Show Makena is Effective for Its Approved Use.
U.S. FDA Says Cder Has Issued Notice of Opportunity for a Hearing (nooh) to Application Holder of Makena, Amag Pharmaceuticals.