AMAG Pharmaceuticals Responds to Recent Complete Response Letter From the FDA for the Single-Dose, Preservative-Free Vial of Makena(R)

AMAG Pharmaceuticals, Inc. (Nasdaq: AMAG) today announced that it responded to the U.S. Food and Drug Administration (FDA), providing the information and data requested in the Complete Response Letter (CRL) received by the company on November 18, 2015. The CRL relates to the company's application seeking approval for a new single-dose, preservative-free vial of Makena (hydroxyprogesterone caproate injection)."We are pleased that we were able to quickly provide a response to the FDA that we believe addresses the requests for additional information and data outlined in the CRL," stated Julie Krop, M.D., chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. "Based on interaction with the FDA since receiving the CRL, we believe that the review may be completed more expeditiously than the standard four-month review target as outlined in the most recent FDA PDUFA Performance Goals document. We look forward to working with the FDA to gain approval and bring the single-dose, preservative-free vial of Makena to market."Makena, the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past, is currently marketed in a multi-dose vial, containing five weekly injections. The multi-dose Makena vial remains available for prescribing and is not affected by the letter from the FDA regarding the single-dose application.For more information about Makena, visit www.makena.com.