WALTHAM, Mass., Dec. 14, 2020 (GLOBE NEWSWIRE) -- 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 have a history of singleton spontaneous preterm birth.

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AMAG Pharmaceuticals Files Submission in Response To the Food And Drug Administration’s Notice of Opportunity for a Hearing and Proposal To Withdraw...