AMAG Pharmaceuticals, Inc. announced that it received a notice from the U.S. Food and Drug Administration (FDA) that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth. The FDA in its letter also notified AMAG that the company has the opportunity to request a hearing on the withdrawal. AMAG is evaluating its full range of potential options. The company has 15 days to respond to the FDA indicating whether AMAG would like to proceed with a hearing. If AMAG does request a hearing, the FDA Commissioner would decide whether to grant AMAG’s request and, if granted, would conduct a hearing and decide whether to withdraw approval following the hearing. This process can take months and during this time Makena and the approved generics of Makena will remain on the market, according to the FDA. AMAG believes the totality of clinical data on Makena supports its continued positive benefit-risk profile and remains fully committed to retaining patient access to approved therapy. Makena and the generic equivalents are the only FDA-approved treatments available for pregnant women at risk for recurrent preterm birth.