Removal of a medicine cleared after an accelerated approval would be a highly unusual step, but it is the way the process is supposed to work. The FDA grants quick clearance to medicines that fill an unmet need, while requiring additional data to further prove safety and effectiveness.
In this case, the FDA approved Makena in 2011 based on a study that showed it could help prevent preterm birth in women who had previously had an unexplained preterm birth, defined as delivery before 37 weeks. The agency then required AMAG to show the medicine could actually improve the health of babies, the ultimate goal of reducing preterm birth.
