Statement Regarding FDA Trial: The UNC Center for Maternal & Infant Health is dedicated to reducing preterm births in North Carolina and that has included the application of the drug 17-alpha hydroxyprogesterone caproate (17P). This drug was approved by the Food and Drug Administration in 2011 to treat women at risk of delivering a second premature baby. AMAG, the company that produces the 17P drug called MakenaTM has recently completed a large, international FDA required trial of the drug. We are currently awaiting the results, including findings regarding subgroup analyses. It is our recommendation that at this time there should be no change in the standard of care concerning the use of this drug among eligible women. We will share any new guidance or information as soon as it becomes available.
Questions? Email Erin McClain.