Posted by Michael Wonder on 15 Dec 2020
AMAG Pharmaceuticals files submission in response to the FDA’s notice of opportunity for a hearing and proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection)
14 December 2020 - AMAG Pharmaceuticals has submitted its response to the FDA’s Notice of Opportunity for a Hearing 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.
The submission of supporting documentation follows upon AMAG’s 14 October 2020 request for a hearing and provides detail on the company’s position in requesting a hearing, recognising clinicians’ decade-long use of this treatment and the public health implications of withdrawing approval.
The response sets out data, analyses, and information demonstrating why Makena should remain available as the only FDA-approved option for women in the U.S. who are at risk for preterm birth, including clinical study results that highlights the evidence of effectiveness of Makena among Black and other minority women.
